Engineering Jobs in Ramsey, NJ
32 positions found — Page 2
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
To support CS Manufacturing and support the manufacturing engineering department.
Job Responsibilities and Essential Duties
- Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
- Participates in Material Review Boards (MRB) Decision process.
- Identifies and implements corrective actions for manufacturing related issues.
- Performs equipment setup and corrective, preventative and calibration maintenance as necessary.
- Installs and validates equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
- Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
- Certifies manufacturing associates in the production processes.
- Evaluates and orders necessary equipment, tools, and fixtures.
Minimum Requirements
- A high school diploma or equivalent is required. Associate Degree in Engineering, Science or related technical field is preferred.
- One to three years of technician experience in a manufacturing environment is required; Experience working in medical device manufacturing or other FDA regulated industry would be ideal.
Required Knowledge, Skills, and Abilities
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Must demonstrate effective verbal and written communication skills.
- Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities. Must be flexible and demonstrate the ability to take initiative.
- Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.
The compensation range for this position is between $26-$31 per hour depending on experience and location.
#LI-MV1
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.
About Us
Imagine the innovation and expertise behind the world’s leading cosmetic brands, brought to you by a distinguished Italian company with a legacy of excellence. Since 1972, Intercos Group has been at the forefront of color cosmetics, pencils, nail polish, skincare, and personal care products. We pride ourselves on being the only cosmetics manufacturer that combines top-tier quality and advanced technology with a global reach and a personalized touch.
With 15 commercial offices and 15 production facilities across 12 countries, Intercos Group brings a local approach to a global stage. We continually set the standard for beauty, crafting exceptional product lines for brands worldwide. As one of the largest suppliers in the cosmetics industry, we are a leading force in the research, development, and production of beauty products, shaping the future of the industry with every season.
Position Summary
The Quality Control Manager is responsible for all aspects of Quality measurement, product inspection and in-process testing in West Nyack, NY. The primary responsibility is to ensure that Quality Control personnel perform the required inspection accurately and as specified by the appropriate quality documentation. This position will allocate resources to efficiently maintain orders on schedule.
Essential Functions
- Quality Control – Product Inspection and Release
- Testing of materials required to produce a finished product and the final product to confirm compliance to issued specifications.
- QC Inspectors are responsible for (but not limited to)
- Physical – Dimensions, Hardness, Drop test, tap test, net weight; Visual – Color (e.g. color matching), Appearance; Sensory - Odor, Texture
- Product Disposition
- Determine final disposition of all products
- Responsible for approving and rejecting all batches
- Management of Product Hold and Disposition
- Quality Control Documentation/Samples for Clients
- Conversion of Product Specifications to Production Line Documentation (checklists, forms)
- Finished Product Documentation to be issued to Clients, (e.g. COA)
- Pre-Shipment Samples to Clients
- Management of Documents and Product Samples Retention Requirements
- Records /Documentation review and sign off for OTC Products
- Monitor and Confirm production operations conforming to specifications or requirements
- Line Clearance
- Critical Process Parameter Line Set Up
- Management of Staff
- Manage QC work schedules; accountable for QC team’s work hours
- Responsible for allocating QC personnel to the production line
- Perform staff performance evaluation
- Responsible for the training of the QC personnel, the discipline and morale of the staff.
- Perform other duties and projects as assigned.
Job Qualifications
- Bachelor’s degree in Applied Sciences or Engineering (e.g., Biology, Chemistry, Physics, or a related field).
- At least 5 years of experience in Quality Management, QA, or QC.
- Proven expertise in Quality Management in cosmetic industry
- Familiarity with Quality Systems, including GMP and GLP, in an FDA-regulated industry.
- Strong critical thinking and problem-solving skills, with the ability to identify and resolve issues promptly, analyze information effectively, and develop alternative solutions.
- Excellent interpersonal and communication skills.
- Capable of managing and developing staff.
- Collaborative team player.
- Self-motivated and proactive.
Job Benefits
Health Insurance: Comprehensive medical, dental, and vision coverage
Retirement Plans: 401(k) plan, often with company matching
Life Insurance: Coverage for employees in the event of death or disability
Paid Time Off (PTO): Vacation days, sick leave, and personal days
Holidays: Paid company holidays and floating holidays
Professional Development: Training programs and opportunities for career advancement
Performance Bonuses: Annual merit increase and/or bonus based on individual performance
Company Events: Team-building activities, social events, and company outings
Employee Assistance Programs (EAPs): Confidential counseling and support services for personal and professional issues.
EEO
Intercos Group is committed to creating a diverse and inclusive workplace where everyone is valued and respected. We believe that a wide range of perspectives and experiences enhances our innovation and success. We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other legally protected status. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to any of these characteristics. We are dedicated to providing a work environment that is free from discrimination and harassment and promotes equal opportunity for all.
About us:
We’re Five Star Millwork — a fast growing millwork & trim work company based in Pearl River, NY, with a reputation for exceptional craftsmanship and attention to detail. From high-end millwork to custom kitchen installations, we take pride in delivering work that’s built to last. Our sister companies, Master Trimmer and Five Star Kitchen Design Center, work hand-in-hand to bring beautiful residential and commercial spaces to life.
The Role:
We're looking for an Estimator with specific finish carpentry experience who is ready to work in a fast-paced culture. The Finish Carpentry Estimator will be responsible for all aspects of preparing hard bid construction cost estimates. Responsibilities include plan take-offs, estimating, proposal preparation, negotiations, pre-construction coordination, client relations, and bid tracking. If you are a self-motivated Estimator with sound judgement, strong communication/interpersonal skills, and confidently develops accurate construction bids then we would love to hear from you! Ideally, you will possess knowledge in construction means and methods, costs, and engineering principles to hit the ground running.
The Responsibilities:
- Read and interpret project documents, understand project logistics, understand project schedule, and develop scopes of work.
- Perform detailed and accurate quantity takeoffs and obtain material pricing.
- Work with Five Star Millwork LLC management and field operation teams to estimate labor production rates, identify project efficiencies, and identify alternate approaches.
- Attend client pre-bid meetings, visit project sites, take notes, and assess site-specific conditions.
- Submit and follow up pre-bid requests for information.
- Prepare bids itemized by specification section and detailed into labor, material, equipment, subcontractor, and overhead costs.
- Present bids to management, succinctly explaining estimate details and project specifics.
- Prepare accurate and competitive hard bid construction cost estimates and submit formal proposals in a timely manner.
- Maintain detailed and orderly project files, adhering to Five Star Millwork quality standards.
- Follow up on bid results.
- Build relationships with clients, contractors, and vendors.
- Perform pier reviews of estimates and proposals. Troubleshoot and resolve estimate issues.
- Maintain past performance databases and spreadsheets.
- Research data on industry standard labor production rates and material costs.
- Maintain the bid board, bid tracking logs, customer history, and material management.
- Identify and recommend improvements to the bidding process.
- Maintain professional & technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
What you bring:
- Bachelor’s degree in Engineering, Architecture, Construction Management, or 10 years’ experience carpentry construction.
- Strong interpersonal and communication skills with the ability to develop and maintain a business relationship with clients and vendors.
- Experience estimating commercial and residential carpentry projects that include finish carpentry, and doors.
- Knowledge of applicable codes and standards.
- Experience with estimating takeoff software.
- Experience estimating construction projects $10,000 to $5,000,000.
- Proficient in Microsoft Windows, Word, Excel, PlanSwift and Quickbooks.
- Superior written and oral communication skills.
Benefits:
- Casual yet professional environment
- Competitive pay
- Paid vacation and holidays
- A yearly review
- Co-workers you enjoy working with
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
The primary responsibility for the Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting testing for regulatory submissions, CAPA execution, writing and executing Test Method Validations, and working with component suppliers. This position will report to the Sustaining Engineering Manager.
Job Responsibilities and Essential Duties
- Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data.
- Write and execute Test Method Validations. Compile, analyze and report testing data.
- Update Design Specifications, Risk Management Plans and Reports, FMEAs, or other risk management documents.
- Investigate and plan CAPA activities
- Communicate and Coordinate activities with other Getinge sites and outside component suppliers.
- Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, and other documentation).
- Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
- Develop processes, methods, tooling, and production controls; supervises their assembly and proofing.
- Prepares presentations reflecting the status and results of projects.
- Lead small projects that support product enhancement and cost savings opportunities.
- This is not an inclusive list of job responsibilities.
Minimum Requirements
- Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical or Manufacturing Engineering with 3-6 years of related experience.
- General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
- Experience with process and equipment validations/qualifications.
Required Knowledge, Skills and Abilities
- Experienced with laboratory physical testing methods Validation/Verification
- Process Validation/Verification
- Knowledge with the following systems: CAPA, Risk Management, Design Controls and Change Management
- Must have strong technical and analytical ability; detail oriented.
- Must have good verbal and written communication skills.
- Strong interpersonal skills.
- Good organizational skills. Must be able to adhere to timelines.
- Knowledge of computer skills including, but not limited to: Microsoft Windows, Word, Excel, Project, PowerPoint, Teams, Solidworks
- Basic understanding of statistical analysis.
Salary range: $94,000.00 - $97,000.00
#LI-LG1
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.
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
The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use catheters. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project.
Job Responsibilities and Essential Duties
- Lead cross-functional project teams in support of Class I - III medical devices.
- Monitor and maintain awareness of new and current product regulations and standards.
- Develop and release all project-related deliverables, including project plan, schedule and budget.
- Manage a project within standardized methods and project models such as Waterfall or Agile
- Lead and support execution of technical and/or cross-functional project work
- Ensure the timely release of critical deliverables within the project.
- Ensure all aspects of the project are in compliance to internal procedures.
- Develop and present periodic status reports.
- Effective communication with project stakeholders, local management, and global management
- Demonstrate leadership when facing uncertainty.
- Understanding of group dynamics to influence team members and lead the project.
- Instill confidence through leadership and actions.
- Identify, support, and promote new concepts and initiatives related to Project Management within the organization.
Minimum Requirements
- BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
- Minimum of 3+ years in project lead role or project management role
- Preferred - experience in medical device or other regulated industry.
- Domestic and/or international travel up to 20%
Required Knowledge, Skills and Abilities
- Experience with Microsoft Project, JIRA, Antura or other project management software
- Experience in leading tasks/projects through a structured, phase-gate process
- Lead and manage technical meetings with cross-functional members.
- Excellent interpersonal, verbal, and written communication skills
- Strong technical writing skills; must be well organized, detail oriented.
- Task oriented and driven to complete assignments on schedule.
- Must have the ability to effectively interface with both technical and non-technical personnel.
- Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
- Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables.
Salary range: $120k - $140k
#LI-LG1
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.
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 Responsibilities and Essential Duties
- Lead and govern design-related CAPA activities across the R&D organization, ensuring timely, compliant, and effective resolution of complex design, verification, validation, and product performance issues.
- Oversee and review root cause investigations using rigorous, data-driven problem-solving methodologies, and ensure corrective and preventive actions are appropriately scoped, risk-based, sustainable, and effectively linked to design controls, risk management, and product lifecycle processes.
- Ensure CAPA records and documentation are complete, accurate, and audit-ready, in compliance with FDA regulations, ISO 13485, and internal quality system requirements.
- Manage and develop the R&D CAPA team, including setting expectations, prioritizing
- workload, providing technical direction, and coaching CAPA specialists and engineers.
- Provide technical guidance, coaching, and mentorship to R&D engineers and CAPA owners on CAPA processes, best practices, timeline development, SOP adherence, and effectiveness verification planning.
- Serve as the primary R&D CAPA interface with Quality, Regulatory Affairs, Operations, and other cross-functional partners to address systemic and cross-product issues.
- Review and approve CAPA plans, timelines, effectiveness verification strategies, and closure rationales to ensure regulatory robustness and high-quality outcomes.
- Support internal and external audits, inspections, and assessments by providing CAPA documentation (e.g., CAPA storyboards), investigation rationale, and subject matter expertise.
- Act as a CAPA subject matter expert within the R&D organization, driving continuous improvement in CAPA execution quality and consistency.
Minimum Requirements
- Bachelor's degree in Engineering or related technical field; advanced degree preferred.
- 6+ years of experience in R&D within a medical device organization with at least 5 years of CAPA processes and regulatory compliance requirements (FDA, ISO 13485).
- 2+ years of leadership experience managing engineering teams.
- Proven experience in managing CAPA for design and development activities
Required Knowledge, Skills and Abilities
- Expert-level understanding of CAPA methodologies, root cause analysis tools (Fishbone, 5 Whys, FMEA), and risk management.
- Strong leadership and team management skills with ability to influence and drive accountability.
- Excellent analytical and problem-solving abilities with attention to detail.
- Effective communication and presentation skills for all organizational levels.
- Experience with drafting statistically sound sampling plans & acceptance criteria for measuring Effectiveness of implemented actions.
- Proficiency in documentation and electronic CAPA systems, Trackwise preferred.
- Deep knowledge of medical device regulations and design control requirements.
Salary range: $145k - $175k
#LI-LG1
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.
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.
JobOverview
The Staff Engineer, Sustainabilityleads sustainability initiatives across product development, operations, and supply chain whileestablishinggovernance frameworks. It ensures measurable environmental impact reductions, compliance with FDA/ISO standards, and trusted performance metrics aligned with business strategy.
Job Responsibilities and Essential Duties
Drive carbon reduction roadmap and eco-design principles.
Lead lifecycle assessments and integrate sustainability into product development.
Collaborate with suppliers on low-carbon initiatives.
Support compliance with ISO 14001, ISO 14040, and FDA standards.
Ensure raw material complianceto include RoHS, REACH, EU MDR Prop65
Define and standardizegovernance & KPI'sacross teams.
Ensure data integrity and consistent reporting.
Build dashboards to track sustainability and performance KPIs.
Review and updategovernanceto align with evolving strategies.
MinimumRequirements
Degree in Engineering, Sustainability,Project Management,or Data&Analytics.
7+years in sustainability, governance, or regulated environments.
Knowledge of lifecycle assessment, ISO frameworks, and BI tools (Power BI, Tableau).
Strong communication, stakeholder management, and analytical skills.
PMP Certification a plus.
Salary range: $98,000.00 - $125,000.00 plus bonus targeted at 10% (depending on overall company performance)
#LI-LG1
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.
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
The Sr. R&D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.
Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.
Job Responsibilities and Essential Duties
- Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
- Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
- Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
- Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
- Collaborate closely with cross-functional partners-including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering-to address systemic and cross-functional issues.
- Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.
- Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
- Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
- Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
- Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
- Serve as a technical CAPA subject matter expert within the R&D organization.
Minimum Requirements
- Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
- 5+ years of experience in R&D engineering within a medical device organization.
- Demonstrated experience managing and executing CAPA activities within product design and development.
- Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.
Required Knowledge, Skills and Abilities
- Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
- Strong analytical and problemsolving skills with exceptional attention to detail.
- Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
- Effective verbal and written communication skills for presenting findings across all organizational levels.
- Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
- Proficiency with CAPA and documentation systems; TrackWise experience preferred.
- Indepth knowledge of medical device regulations, design control processes, and quality system expectations.
Salary Range: $115k - $140k
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.
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
The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
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.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
DESCRIPTION
Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!
POSITION PURPOSE
As the Principal Packaging Engineer, you will serve as the enterprise-wide technical expert and strategic lead in FDA regulated packaging. The position leverage deep knowledge in packaging including but not limited to design, test methods, standards, and industry insights to create and deliver a pipeline of breakthrough innovations and overall organizational improvement.
You will operate with a high degree of autonomy, and lead with accountability projects from concept to commercialization. A proactive approach in identifying opportunity areas and a strong drive for results and overall organizational improvement is essential.
This role requires excellent communication skills to effectively collaborate across functions, influence stakeholders and ensure alignment with organizational goals. The Principal Engineer must take responsibility for technical mentorship and coaching, fostering technical growth and knowledge of junior engineers while strengthening the team’s technical capabilities. As a recognized expert, you will guide internal and external teams on the application of packaging standards (e.g., CCIT, ISO 11607, USP , USP , etc.), and represent the company in regulatory interactions, technical forums, and industry partnerships.
Success requires exceptional problem-solving skills, strategic influence, and proven ability to align cross-functional teams toward breakthrough innovation. This role is accountable for delivering measurable outcomes and ensuring that packaging innovations translate into tangible business impact.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Technical Leadership, Data Analysis and Interpretation
- Demonstrate strong ownership and leadership on technical strategies and problem solving while driving projects from concept to commercialization.
- Own the technical roadmap for packaging innovation and ensure alignment with business priorities.
- Take responsibility for the accuracy, integrity, and impact of technical data used to inform decisions.
- Design and direct meaningful and robust research projects or experiments both internally and externally through relationships with academic institutions and industry partners.
- Facilitate knowledge sharing and foster collaborative research initiatives while mentoring, coaching and guiding junior engineers.
- Analyze experimental data to draw meaningful conclusions from research and guide further development.
- Ensure robust statistical methods are applied where necessary.
- Develop innovative solutions to address technical challenges.
- Act as subject matter expert in packaging for FDA regulated products (expert in packaging standards such as CCIT, ISO 11607, USP , USP , etc).
- Identify, scope and represent the organization at key conferences, seminars and other professional events.
- Stay current and keep stakeholders updated with emerging technologies, regulatory trends, and scientific advancements in packaging.
Innovation and Strategy
- Exhibit a proactive mindset in identifying, vetting and implementing new opportunities for innovation and improvement of the organization.
- Demonstrate ability to think strategically and influence the organization on key initiatives.
- Champion initiatives that deliver quantifiable improvements in product performance, cost efficiency, or regulatory compliance.
- Lead cross-functional teams to bring strategic innovations from concept to launch, ensuring accountability at each stage.
- Develop and execute innovation strategies aligned with business goals, including new technologies, methods, and IP creation.
- Lead the development of new products, technologies, and methods that deliver measurable impact and enhance organizational success.
- Assess and take necessary actions to acquire new in-house technologies to improve PDI’s capabilities.
Project Scoping and Ownership
- Define, communicate and align project goals and request necessary resources for execution cross functionally.
- Hold self and cross-functional teams accountable for meeting project milestones, quality standards, and business objectives.
- Ensure post-launch evaluation and continuous improvement based on performance metrics.
- Demonstrate strong interpersonal and influencing skills to drive initiatives forward and overcome challenges.
- Ensure accountability to milestones and objectives while demonstrating strong ownership, coordination and leadership in project execution, anticipating risks, and implementing mitigation strategies to ensure timely and high-quality delivery.
- Demonstrate excellent communication skills in preparing and presenting progress updates, status, reports and findings to senior level management.
PERFORMANCE MEASUREMENT
- Packaging Leadership and Effectiveness: leads packaging design development that meets intended performance, safety and regulatory requirements
- Project Acceleration and Execution: Demonstrates initiative in shaping project direction, anticipating potential obstacles and proposing solutions to ensure timelines are met or accelerated. Consistently delivers technical work on time, in scope and aligned to evolving business priorities
- Strategic Technical Problem Solving: Anticipates and identifies complex packaging development challenges early, leveraging expertise and leadership to drive resolution paths with minimal rework and high technical rigor.
- Cross-Functional Influence and Alignment: Actively engages and influences cross-functional partners (Regulatory, Marketing, Operations, Quality) to ensure clarity of technical direction, ensure alignment and provide technical strategies, expertise and data to remove barriers impeding project progress
- Pipeline Advancement and Opportunity Identification: Proactively scans internal and external landscapes to identify new opportunities, unmet needs and technology enablers that can strengthen the pipeline and move concepts into development
- Performance will be evaluated based on the ability to deliver projects on time, within scope, and with measurable business impact.
- Expected to take full ownership of assigned initiatives and proactively resolve barriers to success.
QUALIFICATIONS
EDUCATION/CERTIFICATION
- Bachelor’s degree in Packaging, Mechanical Engineering, or related scientific discipline required. Advanced degree preferred.
REQUIRED KNOWLEDGE
- New Product development and leadership in a regulated environment.
- Packaging development for FDA regulated products.
EXPERIENCE REQUIRED
- 8+ years of relevant experience in product development and R&D support, with a demonstrated track record of scientific and packaging development responsibilities.
SKILLS/ABILITIES
- Strong analytical thinking capabilities and mindset
- Strong sense of accountability and commitment to delivering results with excellence and timeliness
- Excellent communication and interpersonal skills
- Ability to make sense of, organize and present complex information
- Proven ability to work independently and take initiative in ambiguous or evolving environments
- Ability to set specific goals for self and others and organize/align the resources to help achieve goals
- Demonstrated ability to manage multiple projects with varying complexity
- Ability to evolve, learn and implement new systems and programs
- Initiative taker, ambitious and driven
- Resourceful and able to find creative and innovative ways to achieve results
- Demonstrated accountability for project outcomes and ability to drive initiatives to successful completion.
- Proactive leader who takes full ownership of challenges and drives results with urgency and precision.
WORKING CONDITIONS
- Mix of lab, manufacturing and office environment
SALARY RANGE:
- $128,000 - $141,000 annually
BENEFITS
PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:
- Medical, behavioral & prescription drug coverage
- Health Savings Account (HSA)
- Dental
- Vision
- 401(k) savings plan with company match and profit sharing
- Basic and supplemental Life and AD&D insurance
- Flexible Spending Accounts (FSAs)
- Short & long-term disability
- Employee Assistance Program (EAP)
- Health Advocacy Program
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
