Cabinet, IQ Jobs in Usa

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Work cross functionally between product development and manufacturing engineering to develop & optimize new manufacturing processes and equipment that will be or has been transferred to production for commercial release.

Job Responsibilities and Essential Duties

• 
  
• Provide input to Product Development on new product designs to address Design for Manufacturing (DFM) and Design for Assembly (DFA) requirements.
  
• Act as a liaison between Product Development, Manufacturing, and Manufacturing Engineering to assure that project deliverables are communicated and agreed upon.
  
• Assess process failure risks and institute methods of detection and mitigation.
  
• Develop & optimize processes required for new products & equipment.
  
• Work with internal design/equipment engineers and/or outside equipment vendors to specify, purchase and develop new manufacturing equipment and tooling.
  
• Work with validation and quality engineers to develop validation plan for new equipment / processes.
  
• Maintain compliance to Quality System and regulations for new processes and equipment.
  
• Complete protocols and reports for Equipment Acceptance Testing (EAT), Installation Qualifications (IQ), and Operational Qualifications (OQ).
  
• Collaborate with other disciplines as needed to execute Performance Qualification (PQ) activities.
  
• Coordinate pilot production / pre-release manufacturing.
  
• Work closely with Manufacturing and Manufacturing Engineering to release new processes and equipment into production.
  
• Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released into production.
  
• Create and implement required documentation including but not limited to; equipment history files, manufacturing procedures, test methods, BOM's, routings, etc.
  
• Responsible for change orders (ECO/DCO's) required to release and/or update controlled items.
  
• Assist in special projects as needed.
  
• Contribute to team effort by accomplishing related duties as requested.
  

Minimum Requirements

• 
  
• Bachelor's Degree in Engineering, or equivalent work experience.
  
• Minimum of 3 years of process engineering, manufacturing engineering, or other related experience.
  

Required Knowledge, Skills and Abilities

• 
  
• Experience with developing and optimizing new manufacturing processes.
  
• Experience with introducing new equipment / processes into production.
  
• Strong problem solving / troubleshooting skills.
  
• Experience with process control & statistical analysis techniques.
  
• Excellent communication skills with the ability to present technical information and prepare written reports.
  
• Able to work in a cross functional team environment.
  
• Strong computer skills including MS Office Suite (Word, Excel, etc.).
  
• Project management experience is preferred.
  
• Experience in a medical device environment or other regulated industry is preferred.
  

Quality Requirements

• 
  
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
  
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
  
• Attend all required Quality & Compliance training at the specified interval.
  
• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.
  

Environmental/Safety/Physical Work Conditions

• 
  
• Ensures environmental consciousness and safe practices are exhibited in decisions.
  
• Duties are performed in an office environment.
  

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Permissions

Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

$80K - 105K - Depending on Experience with 8% STIP

#LI-YA2 #LI-Hybrid

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 
  
• Health, Dental, and Vision insurance benefits
  
• 401k plan with company match
  
• Paid Time Off
  
• Wellness initiative & Health Assistance Resources
  
• Life Insurance
  
• Short and Long Term Disability Benefits
  
• Health and Dependent Care Flexible Spending Accounts
  
• Commuter Benefits
  
• Parental and Caregiver Leave
  
• Tuition Reimbursement
  

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Position Overview

Analytics, Decision Sciences, and Research work as a team, which is uniquely capable of delivering a smartly blended solution by tapping a broad set of analytical skills. The Manager is tasked with partnering with key internal and client teams to oversee measurement, insights and performance optimization deliverables. The ideal candidate can push beyond the obvious answers and quickly use the data, tools, analysis techniques and resource partners to get to the root of story. The Manager is a subject matter expert, but also eager in the desire to learn and further develop the discipline.

Responsibilities

• 
  
• Ownership of ongoing analytics and measurement programs for media planning and investment solutions
  
• Work with internal and client stakeholders to development measurement plans including establishing campaign performance benchmarks, media goals, and statistical framework
  
• Manage dashboard and insights programs across campaigns, competitive intelligence, audience analytics
  
• Ownership of brand health survey research programs (insights development, presentations, optimization recommendations) including coordination with external measurement partners such as comScore, Research Now, and Kantar
  
• Responsible for client communication including reporting, requests and questions
  
• Manage timelines for dashboards and other client insights deliverables
  

Required Skills and Experience

• 
  
• Strong understanding of advertising measurement and analytics, with the ability to provide meaningful insight to the client as well as internal teams
  
• Experience developing insights from third-party ad serving and digital analytics/attribution tools: DoubleClick, Adobe Analytics, Google Analytics, Visual IQ, etc.
  
• Experience with statistical analysis, including test design and sample requirements
  
• Proficiency with at least one statistical software package such as R and Python.
  
• Proven ability to digest and explain complex ideas to a diverse group of stakeholders; including data visualization/dashboards using tools such as Tableau and Datorama
  

Desired Skills and Experience

• 
  
• 4-5 years analytical experience, preferably in the advertising or media industry
  
• General programming experience (SQL, Python, Excel VBA, etc.)
  
• High proficiency in Microsoft Office suite (Excel, PowerPoint)
  
• Ability to work under pressure and manage multiple priorities
  
• Must be a team player but also can work individually
  
• Experience developing custom measurement solutions; including survey design and fielding
  

We offer a Total Rewards package that includes medical and dental coverage, 401(k) plans, flex spending, life insurance, disability, employee discount program, employee stock purchase program and paid family benefits to support you and your family.

The salary range for this position is posted below. Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position, market considerations, budgetary considerations, tenure and standing with the Company (applicable to current employees), as well as the employee's/applicant's skill set, level of experience, and qualifications.

It is our policy to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ethnicity, gender, age, religion, creed, national origin, sexual orientation, gender identity, marital status, citizenship, genetic information, veteran status, disability, or any other basis prohibited by applicable federal, state, or local law.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

The employer will make reasonable accommodations in compliance with the American with Disabilities Act of 1990. The job description will be reviewed periodically as duties and responsibilities change with business necessity. Essential and other job functions are subject to modification. Reasonable accommodations may be provided to enable individuals with disabilities to perform the essential functions.

For applicants to jobs in the United States: In compliance with the current Americans with Disabilities Act and state and local laws, if you have a disability and would like to request an accommodation to apply for a position with Mediabrands, please email .

At American Packaging Corporation (APC), you'll find the packaging career you've been looking for. With competitive salaries, excellent benefits, 401(k) plans, and tuition reimbursement programs, we nurture our employees while advancing and promoting diversity and inclusion. As the leading flexible packaging converter in North America for over a century, APC's longstanding success is fueled from the inside out. We're constantly seeking to improve our internal operations and were named a "Best of the Best" in the Best workplaces in the America's awards for 12 years in a row. It's how and why we engage the best and brightest talent to continue propelling our shared success into the future.

LOCATION: Rochester, NY

SUMMARY: THIS POSITION WILL PRIMARILY FOCUS ON THE VALIDATION TASKS OF THE JOB DESCRIPTION

Apply project management and technical expertise to successfully deliver Validation program goals and outcomes while interacting with customers and meeting their expectations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Validation

• Manage the scope, schedule, and reporting of Validation program activities for individual products and/or customers; ensure status, risks, and open issues are tracked and that all stakeholders (Management, internal/external clients, Business Managers/Project Managers, and regulatory agencies) are informed in a timely manner.
• Write and execute IQ/OQ/PQ validation protocols, and manage the associated deviation process.
• Management and leadership of the change control, calibration, and gage R&R processes.
• Provide hands-on support to manufacturing areas as required to assist with problem-solving and long-term changes that lead to product/process improvements related to process failures. Collect and analyze data to make data-driven recommendations/decisions.
• Participate in process failure investigations.
• Maintain up-to-date knowledge of validation requirements, practices, and procedures, and instruct other site members participating in validation studies.
• Support risk analysis activities, including design and process FMEA.
• Facilitate team meetings as needed on in-depth process and product analysis, risk assessments, decision-making, and other evaluations related to the Validation program.
• Assist in internal and 3rd party audits.
• Provide backup for Quality Supervisors and Quality technicians.
• Drive continuous improvement opportunities utilizing lean six sigma and the seven basic quality tools, to benefit the success of APC, including profit improvement plans, long and short-term strategic objectives, helping establish problem-solving teams and methods, and recommending capital projects that improve Safety, Productivity, and Quality.
• Write and improve manuals, standards, and procedures as needed.
• Use of statistical software and techniques for analysis of data, including Process Capability (Cpk, Ppk), Statistical Process Control (SPC), and Design of Experiments (DOE)
• Other duties as assigned.

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor's degree in science, mathematics, or engineering from a four-year college or university, and two years related experience and/or training; or equivalent combination of education and experience. ASQ certification is preferred.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts. Ability to utilize descriptive statistics (average, variation, standard deviation) to analyze data and support process control and capability analysis. Ability to create and interpret control charts, histograms, Pareto charts, and scatter diagrams. Ability to develop statistically appropriate sampling plans. Ability to use and learn statistical analysis software.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel, and talk or hear. The employee is frequently required to sit and reach with hands and arms. The employee is occasionally required to stand, walk, climb, or balance, and to stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. This position may require manual lifting not to exceed 50 lbs - reference your department-specific JHA (job hazard analysis) for departmental lifting restrictions.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

American Packaging Corporation is committed to equal opportunity for all, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. American Packaging Corporation will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. EOE/AA Disability/Veteran.

If you are interested in applying for an employment opportunity and need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department at .

Job Description:

Overview:

We don't simply hire employees. We invest in them. When you work at Chatham, we empower you - offering professional development opportunities to help you grow in your career, no matter if you've been here for five months or 15 years. Chatham has worked hard to create a distinct work environment that values people, teamwork, integrity, and client service. You will have immediate opportunities to partner with talented subject matter experts, work on complex projects, and contribute to the value Chatham delivers every day.

Chatham is looking for an Analyst to join its Investment Banking team, which provides strategic finance advisory and transaction execution services across a comprehensive range of debt, securitization, and equity capital to companies across all sectors. The team is comprised of capital markets experts who help clients raise capital, solve complex financing challenges, and achieve the best capital markets outcomes.

The ideal Analyst candidate will be intellectually curious with a willingness to work hard, learn quickly, and is process-oriented with strong attention to detail. A successful candidate will thrive in a collaborative environment, have excellent communication skills, and bring prior investment banking or financial services experience to contribute from day one.

In this role you will:

• Support the execution of live transactions and client mandates
• Prepare presentation materials for clients and prospects
• Research various industries, companies and market trends
• Analyze financial statements and corporate SEC filings
• Manage internal proprietary databases to support internal and client decision making
• Assist in executing transactions, including due diligence and coordinating with external parties and client teams
• Other duties and projects as assigned

Your impact:

In contributing to a myriad of projects, the Investment Banking Analyst will enable the greater Capital Advisory team to provide unparalleled capital markets expertise and exceptional client service. The analyst will work under the guidance of the Investment Banking Associates to support all functions of the team, giving this position the opportunity to grow and hone a variety of banking skillsets.

Contributors to your success:

Ideal candidates have at least 1 year in an investment banking, debt capital markets, or a related financial services role and

• Strong interpersonal, verbal, and written communication skills
• Self-starter mentality with superior work ethic and the ability to learn new concepts quickly
• Ability to effectively manage of multiple workstreams while ensuring a high level of accuracy
• Superior analytical and technical capabilities
• Advanced proficiency in Microsoft Excel and PowerPoint
• Familiarity with major data services (Bloomberg, Pitchbook, Capital IQ, etc.)
• Previous experience in credit or financial statement analysis
• The ability to work with large amounts of data and understand causal relationships
• Willingness to obtain, or have obtained, FINRA registration (Series 79)

About Chatham Financial:

Chatham Financial is the largest independent financial risk management advisory and technology firm. A leader in debt and derivative solutions, Chatham provides clients with access to in-depth knowledge, innovative tools, and an incomparable team of over 700 employees to help mitigate risks associated with interest rate, foreign currency, and commodity exposures. Founded in 1991, Chatham serves more than 3,500 companies across a wide range of industries - handling over $1 trillion in transaction volume annually and helping businesses maximize their value in the capital markets, every day. To learn more, .

Chatham Financial is an equal opportunity employer.

Automation Controls Engineer

Location: Lodi, CA

Employment Type: 3-month contract

Hourly Pay Rate: $60-80/hr.

Kelly Engineering is seeking an Automation Controls Engineer for our client, a leading medical device manufacturer. You’ll work on a critical project upgrading and validating PC-based automation systems to the latest Windows 11 platform, ensuring manufacturing stays state-of-the-art and compliant with FDA regulations.

Key Responsibilities:

• Upgrade PC-based control systems to Windows 11 IoT LTSC and ensure vital automation applications are fully compatible.
• Perform thorough testing of system upgrades and document outcomes according to Good Manufacturing Practices (GMP).
• Install and deploy upgraded systems at the manufacturing site in Lodi, CA.
• Validate the installation by executing Installation and Operational Qualification (IQ/OQ) protocols consistent with FDA regulations.
• Work with applications such as Rockwell FactoryTalk View ME Edition, Cognex Designer Vision-Pro, SPEL+, Epson programming, and data acquisition systems.

Requirements:

• Bachelor’s degree in Engineering.
• 3+ years of relevant experience in automation controls.
• Advanced skills in PLC programming (Rockwell RSLogix 5000) and FactoryTalk View ME Edition HMIs.
• Strong experience with Cognex Designer Vision-Pro (including deep and edge learning technology).
• Solid knowledge of robotics, motion control, servo systems, and pneumatic actuators in high-speed manufacturing.
• Prior experience in FDA-regulated industries.

Why Apply:

• Lead high-impact automation projects in the medical device sector.
• Collaborate with talented engineers and work at the cutting edge of controls and manufacturing technology.
• Be part of a company committed to quality and innovation.

Job Title: MES Software Implementer

Location: Fully Remote

Industry: Life Sciences

Employment Type:Full-Time

About the Role

We are looking for an experienced MES Software Implementer with deep expertise in POMSNet to join our team. This role focuses on deploying and configuring Manufacturing Execution Systems (MES) for clients in the life sciences industry, ensuring compliance, efficiency, and seamless integration with existing systems. As this is a fully remote position, strong communication and self-management skills are essential.

Key Responsibilities

• Lead the implementation and configuration of POMSNet MES solutions for life sciences manufacturing environments.
• Collaborate with client stakeholders to gather requirements and design system workflows, recipes, and electronic batch records (EBRs).
• Perform system integration with ERP, LIMS, and automation platforms.
• Conduct validation activities, including IQ/OQ/PQ documentation and execution.
• Provide technical support, troubleshooting, and training for end-users.
• Ensure compliance with GMP, FDA, and other regulatory standards throughout the implementation process.
• Drive continuous improvement initiatives and contribute to best practices for MES deployment.

Required Qualifications

• Proven experience implementing POMSNet MES in life sciences or pharmaceutical manufacturing.
• Strong understanding of MES concepts, GMP compliance, and regulatory requirements.
• Experience with system integration and data exchange between MES and enterprise systems.
• Excellent problem-solving skills and ability to work independently in a remote setting.
• Strong communication and stakeholder management skills.

Preferred Qualifications

• Familiarity with SQL databases and scripting for MES customization.
• Experience with other MES platforms or automation technologies.
• Background in pharmaceutical or biotech manufacturing environments.

What We Offer

• Fully remote work flexibility.
• Competitive compensation and benefits.
• Opportunity to work on high-impact projects in the life sciences sector.
• Professional development and training opportunities.

Minimum experience of 4 years in Medical devices - Manufacturing Engineering.

Good Experience working on Process Validations (IQ, OQ, PQ)

Experience developing manufacturing processes and technologies, which includes process characterization

Experience working on PFMEAs

Experience performing Data analysis (Minitab)

Evaluate process and design alternatives based on Design for Manufacturability principles.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Industry: Pharmaceuticals

Title: Quality Control Analyst III

Job ID: NORT000022

Location: Norton, MA

Duration: 10 months contract (+Possibility of extension)

This position is onsite and will be primarily located in Norton, MA. There may be occasional responsibilities at a secondary location in Cambridge, MA.

Overview

The Quality Control Operations (QCO) LEQ Analyst III plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. This position is responsible for supporting and executing laboratory equipment qualification activities in compliance with USP and applicable regulatory requirements. This role ensures laboratory instruments are fit for intended use throughout their lifecycle and supports data integrity, compliance, and continuous improvement within the laboratory quality system. By ensuring these critical activities are executed with precision, the LEQ Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions .

Key Responsibilities (including but not limited to):

• Perform and support laboratory equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with USP .
• Classify laboratory instruments (Groups A, B, and C) and determine appropriate qualification strategies.
• Review and approve qualification protocols, test scripts, and reports.
• Support equipment lifecycle management, including calibration, maintenance, requalification, and change control.
• Review vendor documentation (URS, manuals, certificates) to support qualification and compliance.
• Investigate and document deviations, discrepancies, and out-of-tolerance events related to equipment performance.
• Ensure qualification activities comply with internal SOPs, cGMP, data integrity principles, and regulatory expectations (e.g., FDA, EMA).
• Collaborate with laboratory staff, quality assurance, validation, facilities, and vendors to resolve equipment-related issues.
• Maintain accurate and complete documentation in electronic quality systems.
• Support audits and inspections by providing qualification documentation and technical explanations as needed.
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to laboratory processes, particularly those related to efficiency and reliability.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field ;
• Pharmaceutical/Biotech industry experience with 6-10 years in a GMP Quality Control function or equivalent, relevant industry experience
• Hands-on experience with laboratory equipment qualification in a regulated environment.
• Strong working knowledge of USP and laboratory instrument lifecycle management.
• Familiarity with cGMP, GLP, and data integrity requirements.
• Experience with common laboratory instruments (e.g., HPLC, GC, balances, dissolution, UV/Vis, pH meters, spectrometers).
• Ability to write clear, compliant technical documentation.
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Experience in pharmaceutical, biotech, or contract testing laboratory environments.
• Exposure to computerized systems validation (CSV) as it relates to laboratory instruments.
• Familiarity with calibration and maintenance programs.
• Experience supporting regulatory inspections or internal audits.

Position:

The Engineering Project Manager will report directly to the PMO Manager and will be responsible for leading and managing assigned NPI Projects from project initiation through production hand-off.

Key Goals:

The EPM goal when managing projects is to meet or exceed internal and external customer expectations while maintaining the scope, quality and any costs associated with the project. The Engineering Project Manager will oversee and manage the activities of multiple projects involving contracted component/assembly processes, equipment/tooling builds, and plant layout tasks that support all three AVNA facilities.

Responsibilities:

• The EPM will facilitate communication between the customer and the internal project team. The EPM will guide contractual conversations, technical conversations, and production conversations.
• The EPM manages activities for cross-functional team members that include Manufacturing Engineers, Quality Engineers, Automation Engineers, Toolmakers/technicians, Maintenance, product supervisors, estimating/quoting/sales, Buyers/Planners, outside vendors, etc.
• Develops and maintains multi-phase project plans and timelines while adhering to scope, quality and project costs. Any milestone dates, risks, or failures must be clearly communicated to the customer in a timely manner.
• Identifies project risks and addresses accordingly during all stages of the project. The EPM must understand the use of technical and financial information from past projects and the experience of subject matter experts.
• The EPM will collaborate with a multi-functional team to resolve technical challenges. The EPM will assist with troubleshooting, data analysis and in-depth evaluation of the process, equipment or tooling when needed.
• Oversees all project operation rate variants as it relates to gross profit margins. The EPM alters/improves processes with the technical lead during the NPI stage as it relates to cost, efficiency or quality.
• Works with outside suppliers to develop or confirm material, component or assembly processes.
• Works with outside vendors for gages, tooling, equipment or services that are required within the project plan or capital expense.
• Technical writing will be owned by the EPM such as IQ/OQ/PQ protocols and reports. The EPM must ensure other technical documents are correctly completed during the specified project phase per any phase gates.
• Convey meeting minutes with specific actions/timing for all internal and external meetings that are led by the EPM.

Requirements:

• 5+ years of project management experience as an engineer or project manager, preferably in the medical device industry.
• Hands-on technical support in the Berlin, CT facility and New Britain, CT facility is required.
• Formal project management training (PMP certified) is preferred.
• Skilled in a project management software product (Smartsheet preferred)
• Engineering skills or technical skills surrounding manufacturing: Tooling design, metal stamping/milling/turning/grinding, injection molding, laser processing, assembly processes.
• Skilled in a 3D CAD software (Solidworks preferred) and 2D CAD software (AutoCAD or Draftsite preferred).
• Experience with PPAP (production part approval process) is preferred.
• Must be able to interpret technical drawings, product requirements and design specifications.
• Understanding of lean manufacturing/six sigma and trained in a statistical software for MSAs and Capability studies (green belt certification and Minitab preferred, respectively)
• Outstanding verbal and written communication skills for different cross-function team members and customer interface.
• Ability to self-educate and learn new processes
• ISO13845 experience is recommended

PURPOSE

Primary role is to supports manufacturing and quality operations to ensure compliance with cGMP, FDA, and applicable regulatory requirements. This role is responsible for maintaining and improving quality systems, supporting investigations and CAPAs, and partnering with cross-functional teams to ensure the consistent manufacture and release of high-quality pharmaceutical products.

REPORTS TO

Reports to the Quality Control Manager and supports the Quality Control organization. This role will interact with cross-functional departments including Manufacturing, Research and Development, Analytical Development, Quality Assurance, and Facilities, as well as external vendors and service providers, to support Quality Control operations, equipment, and quality system activities.

DUTIES AND RESPONSIBILITIES

• Author, execute, and maintain equipment qualification protocols and reports (IQ/OQ/PQ as applicable) in support of Quality Control laboratory operations.
• Author, execute, and maintain cleaning validation protocols and reports for equipment and laboratory areas, ensuring compliance with cGMP and internal requirements.
• Support the Quality Control organization in the management of quality system records, including change controls, CAPAs, deviations (DEVs), and out-of-specification (OOS) investigations, ensuring timely, thorough, and compliant documentation.
• Participate in and support root cause investigations, risk assessments, and the development of effective corrective and preventive actions.
• Coordinate with internal stakeholders and external vendors to ensure laboratory equipment calibration activities are completed accurately and within required timelines.
• Develop, revise, and maintain SOPs, work instructions, and processes related to equipment qualification, validation, calibration, and quality systems.
• Provide quality engineering support to operations to maintain a state of control and readiness for internal, client, and regulatory inspections.
• Review and assess the impact of proposed changes on systems, equipment, and processes, and support implementation through the change control process.
• Ensure documentation and activities comply with cGMP, FDA regulations, data integrity principles, and company policies.
• Collaborate cross-functionally with Quality Assurance, Manufacturing, R&D, Analytical development, and other stakeholders as required to support company objectives.
• Identify opportunities for process improvement within quality systems and contribute to continuous improvement initiatives.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Bachelor’s degree or higher in a life or chemical science; chemical engineer, chemistry, analytical chemistry, or a similar science-based degree preferred.
• Minimum of five years of experience in Quality Control within a pharmaceutical, chemical, or manufacturing environment, with at least two years of experience in a validation or quality engineering role.
• Strong knowledge of cGMP, FDA, ICH, and USP requirements.
• Hands-on experience with analytical techniques.
• Strong technical writing skills with a quality-oriented mindset, and a proven ability to author and execute protocols in laboratory and manufacturing environments.
• Strong interpersonal skills, with a demonstrated ability to work effectively, professionally, and respectfully in a team-based environment, and to collaborate with peers, customers, line management, and technical subject matter experts.

WORKING CONDITIONS / PHYSICAL REQUIREMENTS

• Ability to stand for up to 8 hours per day.
• Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening.
• Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping.
• Occasional lifting and/or moving up to 50 pounds.

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time.

Positions posted for Benuvia Operation are not intended for or open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.

HCLTech is looking for a highly talented and self- motivated Design Quality Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Design Quality Engineer

Job ID: 78923

Position Type: Full-time with HCLTech

Location: Palm Beach Gardens, Florida

Role/Responsibilities:

Summary

The Design Quality Engineer will act as the quality representative and design control lead on cross-functional new product development (NPD) and sustaining engineering teams. This role ensures that orthopedic implants and associated instrumentation are developed and manufactured in compliance with internal QMS, FDA 21 CFR 820, ISO 13485, and ISO 14971 standards. The ideal candidate will facilitate risk management activities, verify design outputs, and ensure a smooth design transfer to manufacturing

Key Responsibilities

• Design Control Leadership: Lead and support Design Control activities (planning, design inputs, outputs, verification, validation, and design transfer) across the product lifecycle.
• Risk Management: Facilitate and lead risk management activities, including development of Risk Management Plans, Hazard Analysis, and Design Failure Mode Effects Analysis (DFMEA) for orthopedic products.
• Verification & Validation (V&V): Approve design verification/validation plans, protocols, and reports to ensure compliance with product requirements, including mechanical testing, tolerance analysis, and anatomical lab testing.
• Design Transfer: Ensure the successful transfer of new products to production by assisting in process validation requirements (IQ/OQ/PQ) and reviewing manufacturing documentation.
• Technical Documentation & Audits: Review and approve Design History Files (DHF) and Device Master Records (DMR) for conformance. Support internal and 3rd party audits (FDA/Notified Body).
• Post-Market Surveillance (PMS): Utilize post-market data and analytics to report on product performance in the field, providing feedback to R&D for continuous improvement.
• Root Cause Analysis: Lead quality-related problem-solving and root cause investigations for design-related issues, complaints, and CAPAs.
• Regulations: Strong understanding of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Technical Skills: Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and machining methodologies (titanium and stainless steel).
• Tools: Proficient in statistical software tools (e.g., Minitab) for data analysis and risk analysis.

Preferred Skills

• Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt.
• Experience with EU MDR regulatory submissions.
• Experience with surgical instrumentation and/or implantable devices.

Core Competencies

• Strong analytical, problem-solving, and critical thinking skills.
• Effective communication and interpersonal skills to work within multi-disciplinary, cross-functional teams.
• Detail-oriented with a focus on compliance and accuracy.

Pay and Benefits

Pay Range Minimum: $38.46 per hour

Pay Range Maximum: $47.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

Company Overview

Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients’ lives.

Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery.

Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work!

Senior Manufacturing Engineer

Responsibilities:

• Design new and revise existing tools and fixtures for assembly, test, and inspection
• Create test protocols for qualifying new products and assemblies
• Develop and document IQ, OQ, PQ and maintenance protocols for new equipment and fixtures
• Develop and implement automation/semi-automation equipment and fixtures
• Participate in Material Review Board, evaluate and disposition discrepant material, conduct failure root cause analysis, develop rework and repair methods, identify and document corrective and preventative action
• Create engineering design and process change orders with required documentation, technical justification/change effects analysis, and impact to operations
• Create, document, and conduct training and certifications for fixture/equipment operation, and critical methods
• Revise existing product designs for improvement or new line extensions
• Develop test equipment and methods for mechanical, electrical, hydraulic, and pneumatic devices and systems
• Develop and maintain production assembly, test, and inspection procedures through product life cycle
• Develop verification and validation protocols for equipment and processes, including validation of cleaning, packaging, and sterilization
• Develop automated data collection and reporting methods
• Lead production process quality improvement
• Determine training and certification requirements for assemblers and technicians for production processes and equipment
• Provide product failure analysis support for customer complaints and returns
• Workflow design, yield improvement, waste reduction, time and motion efficiency studies
• Create and maintain Product and Process FMECA through product life

Requirements:

• Bachelor’s degree in Engineering (Manufacturing, Mechanical, or equivalent) with 5-7 years of experience in medical device manufacturing or related manufacturing environment
• Direct experience in medical device or highly regulated environment
• Certified SolidWorks Associate or 3+ years of equivalent experience
• Microsoft Office applications, Excel power user
• Proficiency with inspection tools and methods
• Solid understanding of design change requirements and processes in FDA regulated manufacturing environment
• Ability to perform Gage R & R Analysis for equipment qualifications
• Ability to use Design of Experiments methods to support process improvement

Desirable Skills and Experience:

• Experience with metal machining and fabrication and finishing methods and equipment
• Swiss watch or jewelry manufacturing industry with insights into small tools, equipment, techniques
• Experience with color anodizing, electropolishing, chemical etching, laser etching
• Clean room, aqueous cleaning, and sterilization qualification and monitoring
• Lean manufacturing process implementation or support
• Mechanical specification using GD&T
• Quality analysis using MiniTab

Salary range for this position is $120k-$145k per year which is the general base range for a successful candidate in the State of Washington. The successful candidate’s actual pay will be based on various factors such as skills, qualifications and experience.

This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits.

MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law.

Please note that only qualified candidates will be contacted for further consideration.

No Recruiters or Agencies Please

ob Title: Automation Engineer/Technical Lead

Location: Foster City, Onsite (5 days a week)

Duration: Long Term Contract

Notes: Minimum of 3-5 years of experience administering or integrating process control systems, specifically. Rockwell FactoryTalk-based systems and/or Inductive Automation's Ignition based systems. Experience interfacing with PLCs, SCADA, or historian systems.

Job Summary:

We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates, administering system security, resolving technical issues, and ensuring system reliability under the direction of a System Manager.

Key Responsibilities:

• Perform periodic system maintenance activities such as System Maintenance, Server Maintenance, System Audit Trail Review, User access reviews and coordinating with IT and drive completion of server maintenance.
• Monitor system performance, identifying bottlenecks and working with system manager to implement solutions to optimize system UI/UX. Perform periodic system health checks.
• Validate compatibility of OS patches with the application and co-ordinate with IT for installation of patches and perform post-patch verification testing on a periodic basis.
• Work with the System Manager to evaluate application patches on a periodic basis, perform installation of approved patches and assist Validation Engineers in regression testing following patch installation.
• Administering system security and access control such as creating, managing and updating user accounts within the system environments per applicable procedures.
• Collaborating with the System Manager to create and maintain training content and provide training to users requesting access.
• Troubleshoot and resolve hardware, software issues and collaborate with IT to resolve network-related issues impacting system availability and performance.
• Provide technical support during change management and assist automation engineers and/or system integrators in deploying changes to systems.
• Provide technical support for validation engineers performing annual backup and restore testing as well as disaster recovery testing.
• Assist validation engineers in installation, operational and performance testing as well as perform IQ/OQ/PQ testing, when required.

Qualifications and Skills:

• Bachelor's degree in computer science, Engineering, Industrial Automation, Information Technology, or a related field (or equivalent experience).
• Minimum of 3-5 years of experience administering or integrating process control systems, specifically. Rockwell FactoryTalk-based systems and/or Inductive Automation's Ignition based systems. Experience interfacing with PLCs, SCADA, or historian systems.
• Excellent communication skills and the ability to work collaboratively with technical and non-technical teams.
• Experience deploying and configuring systems in a production environment. Strong troubleshooting skills with the ability to diagnose and resolve complex technical issues efficiently.
• Demonstrated experience working in a GMP-regulated environment with a thorough understanding of FDA regulations (e.g., 21 CFR Part 11).
• Familiarity with system validation, change control, and documentation practices in a regulated setting.
• Experience in authoring and executing change control for implemented GMP systems.
• Ability to prioritize tasks and manage multiple responsibilities in a fast-paced environment.
• Keen attention to detail and a commitment to maintaining compliance with regulatory standards.

Preferred Skills:

• Relevant certifications (e.g., Rockwell Automation, Ignition, or similar) are highly desirable.
• Proficiency in operating system administration (windows and Linux), network administration, Python scripting, or automation is a plus.

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Plant Engineer is responsible for maintaining, optimizing, and improving manufacturing and packaging equipment within a pharmaceutical production facility. This role focuses on ensuring equipment reliability, regulatory compliance, and operational efficiency, with a strong emphasis on Vertical Form Fill Seal (VFFS) packaging systems used in pharmaceutical or medical product packaging.

]The Plant Engineer will support production operations through equipment troubleshooting, preventive maintenance programs, process improvements, and engineering projects while maintaining compliance with cGMP and FDA regulatory requirements.

Key Responsibilities

Equipment Reliability & Maintenance

• Provide technical support for manufacturing and packaging equipment, including Vertical Form Fill Seal (VFFS) machines.
• Troubleshoot mechanical, electrical, and automation issues affecting production equipment.
• Develop and maintain preventive and predictive maintenance programs.
• Coordinate repairs and upgrades with maintenance technicians and external vendors.
• Monitor equipment performance and implement improvements to increase uptime and efficiency.

Packaging Equipment Expertise

• Maintain and optimize VFFS packaging lines, including forming, filling, sealing, and product handling systems.
• Support setup, changeovers, and line optimization for packaging operations.
• Work with production teams to minimize downtime and improve throughput.
• Evaluate and recommend packaging equipment upgrades or modifications.

Regulatory Compliance & Validation

• Ensure all engineering activities comply with FDA regulations, cGMP, and pharmaceutical industry standards.
• Support equipment qualification activities including:
• IQ/OQ/PQ
• Process validation
• Packaging validation
• Maintain accurate technical documentation, SOPs, and maintenance records.

Qualifications/Education

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or related field or equivalent experience
• 5+ years of engineering experience in pharmaceutical, medical device, or regulated manufacturing.
• Hands-on experience with Vertical Form Fill Seal (VFFS) packaging equipment.
• Experience in FDA-regulated or cGMP manufacturing environments.