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At Rite-Hite, your work makes an impact. As the global leader in loading dock and door equipment, we design and deliver solutions that keep our customers safe, secure, and productive. Here, you'll find innovation, stability, and the chance to grow your career as part of a team that's always looking ahead.

With a promotion comes a new opportunity to join us!

Our Administrative team is looking for a new addition to the team.

This position is responsible for ensuring customer satisfaction by timely and professional administration of all customer issues regarding their new equipment orders. The schedule of this position would be 7:30AM-4:30PM in office with the benefit of a hybrid schedule after training. Our facility is located near Carowinds Amusement Park, in Charlotte, NC.

Rite-HiteCustomer Service Representatives serve as the key conduit between our customers and our sales department.

• Gathering necessary order related information from all parties and assuring it is accurately communicated to those who need it. If unable to secure necessary information, this position is responsible for securing the assistance of the District Operations Manager, as needed.

• Coordinate information flow for new equipment jobs using order logs, order management, and entry systems.

• Create and maintain accurate and complete job files, work orders and information to include maintenance, reconciliations and filing processes.

• Work with customers, contractors, and vendor to assure order requirements are achieved, orders are released, and shipping dates meet customer expectations.

• Review vendor invoices for accuracy and properly code and post into corporate order management system and that they meet corporate accounting requirements.

• Review job costs and gross profit to ensure accurate invoicing and minimize profit erosion.

• Assist with resolution of collections issues.

• Ensure incoming new equipment orders meet standards and advise appropriate parties if they do not.

• Create and maintain accurate and complete job files.

• Create Work Orders to support the equipment installation process.

• Create purchase orders for allied equipment.

• Maintain a strong working relationship with supported district's Installation Coordinators.

• Enter and administer equipment orders for both Rite-Hite and allied equipment vendors following the appropriate procedures for each vendor. Maintain a smooth order flow, assure release dates and shipping schedule meet customer requirements. Expedite orders when necessary.

• Review vendor invoices for accuracy and properly enter into the system for payment.

• Process all submittals, contracts, insurance certificates, and any other similar documents necessary to release and invoice orders.

• Assist District Management and sales personnel in resolving collections issues. This includes effectively interfacing with customers to ascertain and document billing procedures to assure timely payment of Arbon invoices.

• Work to consolidate shipments to minimize freight costs while meeting customer requirements.

• Review completed job files to ensure that profit erosion is minimized. Analyze and communicate variances to District management as required.

• Cross-train with other administrative personnel to provide additional help during heavy workloads or back-up during absences.

Rite-Hitesells the best, and we hire the best. Successful candidates will possess the following qualifications:

• One year of related experience minimum. Prior experience in supporting a field service operation is helpful.

• A commitment to quality. Prior experience in an ISO-certified or similar quality program is a plus.

• Good attention to detail

• Ability to juggle multiple projects without dropping the ball

• Good communication and customer service skills are also essential

#hybrid

#LI-LC1

What We Offer

At Rite-Hite, we take care of our people - because when you're supported, you can do your best work. Our benefits are designed to support your health, your future and your life outside of work:

• Health & Well-being: Comprehensive medical, dental, and vision coverage, plus life and disability insurance. A robust well-being program with an opportunity to receive an extra day off and more.

• Financial Security: A strong retirement savings program with 401(k), company match, and profit sharing.

• Time for You: Paid holidays, vacation time, and personal/sick days each year.

Join us and build a career where you're supported - at work and beyond.

Rite-Hite is proud to be an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under federal, state, or local law.In accordance with VEVRAA, we are committed to providing equal employment opportunities for protected veterans.We are also committed to maintaining a drug-free workplace for the safety of our employees and customers.

Our employer is a leading provider of premium metal payment cards and secure authentication solutions. Headquartered in Somerset, New Jersey, the company serves major financial institutions, producing over 30 million metal cards annually and holding a dominant share in the premium metal card segment. It also offers advanced digital security through a proprietary platform that includes three-factor authentication and cold storage for digital assets, generating over $420 million in annual sales.

• Salary range: 85-150k USD
• Annual Bonus: Up to 15% (contingent upon a combination of company's and personal performance).

Position Summary

We are seeking an Advanced Manufacturing Engineer (Automation) who will perform the planning, design, and implementation of automation solutions across our production lines. This role involves designing and building custom machines in-house as well as managing external integrators to deliver turnkey automation systems. The ideal candidate will have a proven track record in machine design, supplier management, and project execution in high-volume manufacturing environments.

This position is critical to driving automation initiatives that improve efficiency, scalability, and quality in a multi-million-unit-per-year production setting.

Key Responsibilities

• Automation System Design & Implementation
• Design and develop custom automation equipment using SolidWorks.
• Lead full lifecycle of automation projects: concept, design, build, installation, and validation.
• Collaborate with external integrators and manage suppliers for outsourced machine builds.
• Production Line Automation
• Plan and implement automation solutions for assembly and packaging lines.
• Integrate robotics, PLCs, vision systems, and material handling equipment.
• Project Management
• Develop project timelines, budgets, and resource plans.
• Ensure projects meet performance, quality, and safety standards.
• Safety & Compliance
• Ensure all automation systems comply with OSHA, environmental, and company safety standards.
• Implement risk assessments, machine guarding, and lockout/tagout procedures.
• Maintain documentation for regulatory compliance and audits.
• Continuous Improvement
• Identify automation opportunities to reduce labor, improve throughput, and enhance quality.
• Drive cost reduction and efficiency initiatives through innovative automation solutions.

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.

Experience

• 5+ years of hands-on experience in machine design and automation engineering.
• Proven track record of designing, building, and installing machines in high-volume manufacturing environments.

Technical Expertise

• SolidWorks proficiency for machine and fixture design.
• Strong knowledge of automation technologies: robotics, PLC programming, vision systems, conveyors, and material handling.
• Experience with supplier management and working with external integrators.
• Understanding of system design, defect analysis, and process optimization.
• Familiarity with SPC, Six Sigma, and DoE methodologies for data-driven improvements.
• Ability to troubleshoot automation and mechanical issues, conduct root cause analysis, and implement corrective actions.

Preferred

• Experience designing full production lines.
• Familiarity with high-speed automation for multi-million-unit production.
• Knowledge of Lean Manufacturing principles.
• Exposure to ISO 13485 or automotive quality standards.
• Experience with robotic integration, automated quality inspection, and vision systems.

Our employer believes in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to:

• Medical, Dental & Vision Coverage
• Flexible Spending Accounts (FSA)
• Company-Paid Life and Disability Insurance
• 401(k) with Company Match
• Paid Time Off & Paid Holidays
• Annual Bonus Opportunities
• Employee Assistance Program (EAP)
• Career Advancement Opportunities

**** Benefits eligibility and details will be shared during the hiring process.

Angstrom Group of Companies is a leading Tier 1, full-service supplier providing high-quality solutions to automotive and industrial original equipment manufacturers (OEMs). Angstrom offers a diversified product portfolio with vertically integrated manufacturing capabilities. Angstrom has 30+ manufacturing locations across North America, South America, and Europe. Core manufacturing units process Metals (Casting, Stamping, Forging, Welding, Machining, and Assembly), Resin (Injection Molding, Foam, and Fiber), and Electrical components (Wire Harnesses, Lighting, and assembly modules).

Minimum of 4 years of actual on-the-job experience ( no internship or fresh graduates)

RESPONSIBILITIES:

AME leads new projects right from the inception of the program till manufacturing launch, which includes prototype part development, APQP, manufacturing process planning, FMEA, selection of equipment, tooling design, developing infrastructure, conducting trial production, installation of manufacturing cell, executing PPAP, proving Run Rate, monitoring initial production run, and sign off from production. Implement advanced manufacturing techniques in existing production processes to maximize throughput / OEE. Resolves issues with design, manufacturability, or build sequences.

• Develop new product process design, PFD, FMEA, and prepare manufacturing equipment proposals to execute project deliverables in coordination with the Cross Functional Team
• Develop and execute prototype plans as per customer requirements.
• Recommend new manufacturing equipment by identifying vendors, evaluating equipment capabilities, service history, and service support. Secure buy-off from the CFT team.
• Ensure that sourced equipment and tooling meet established standards and project requirements
• Lead pre-production activities in coordination with the production department
• Lead PPAP and Run Rate to meet project deliverables
• Inputs and configures BOM’s, routing and master data to the ERP system.
• Develop process drawings, manufacturing instructions, control plan and work instructions for new products, machining, welding, assembly fixtures, and tooling
• Develop financial evaluations of potential major capital investment projects and provide documentation of investment vs payback to the superior.
• Coordinate manufacturing changes for the approved Engineering Change Request
• Evaluate existing methods of operations, routings, processes, tooling, etc., and recommend and/or initiate changes or modifications to update and achieve optimum operating efficiencies and manufacturing economies.
• Develop and manage plant layouts, CAD drawings, and operational design concepts
• Install and conduct equipment capability and certifications with the help of maintenance
• Coordinate and conduct new project PDT meetings with the customer and supplier.
• Application of lean concepts and capacity planning
• Application of error-proofing techniques
• Periodic review of process capability studies and initiate action to reduce FMEA / RPN
• Identify and address safety and ergonomic issues, as identified.
• Keep regular communications, periodic meetings with program management on new program awards, and the status of awarded programs
• Support Sales on RFQs, cost estimation, and technical presentation to seek new business
• Do participate in corrective preventive actions for customer and internal complaints
• Must be able to take the production engineer role in case new project activities are completed

QUALIFICATION AND KNOWLEDGE:

• Associate Diploma or Degree in Industrial / Mechanical / Manufacturing Engineering required
• Minimum of 4 years of actual on-the-job experience ( no internship or fresh graduates) in Engineering, product development, manufacturing in Automotive and/or Automotive Supply base
• Must have process experience in Machining, Welding (MIG, TIG), Robotic welding, Press Assembly, Fixture, Automation and cutting tools knowledge required
• Adequate knowledge of Problem-Solving methods, SPC and SQC tools required
• Auto CAD, Solid Works skill set
• Highly knowledgeable in APQP process, PPAP, PFMEA, PFD, Control Plan and WI
• Knowledge in GD&T and Lean manufacturing
• Knowledge in International Quality Management System - IATF 16949:2016/ISO 14001 /OHSAS and State Law in Industrial Regulations
• Proven ability in execution of project plans that have achieved the identified targets
• Understanding safety procedures and ability to work in a manufacturing environment
• Must be able to train, assist, lead, direct, instruct and discipline employees
• Strong sense of time management and urgency
• Ability to manage, navigate unexpected challenges with a focus to rapidly find solutions

PHYSICAL REQUIREMENTS:

• Sitting, squatting, walking, bending 8 –10 hours per day
• Must be able to lift 50 lbs. or more.
• Must be able to work in different weather conditions
• Exposure to production environment

WORK ENVIRONMENT:

• This role functions in a welding, assembly and machine shop environment
• This role routinely uses standard and special purpose equipment such as CNC machines, robots, welding, assembly fixtures and tools
• Technicians often work in assembly lines or automated production floors

SAFETY REQUIREMENTS:

• Must wear Personal Protective Equipment when in a production area

Angstrom NA LLC is an Equal Opportunity Employer. Employment at Angstrom NA LLC is governed by merit, qualifications, and professional competence. Angstrom NA LLC does not discriminate against any employee or applicant because of race, creed, national origin/ethnicity, color, religion, gender identity/expression, sexual orientation, marital status, age, veteran status, disability status, genetic information, pregnancy or related conditions, or any other basis protected by law.

Applicants requiring reasonable accommodation to the application/interview process should notify the Human Resources Department.

We are seeking an experienced Contract Project Manager to lead the design, construction, validation, and operational readiness of a new 503B Outsourcing Facility in Charleston, SC. This project involves the build-out of a modular cleanroom pharmaceutical manufacturing area, within an existing structure, to be compliant with U.S. FDA 503B regulations and current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211.

The Project Manager will oversee the full lifecycle of the facility build, including planning, vendor coordination, cleanroom installation, utilities integration, validation, regulatory readiness, and handoff to operations.

Key Responsibilities

Project Leadership & Execution

• Lead end-to-end execution of a modular cleanroom manufacturing and supporting structure area build.
• Develop and manage detailed project plans, budgets, schedules, and milestones.
• Coordinate cross-functional stakeholders including Engineering, Quality, Regulatory, Validation, Manufacturing, and Executive Leadership.
• Serve as the primary point of contact for contractors, cleanroom vendors, equipment suppliers, and consultants.
• Proactively identify risks and implement mitigation strategies to maintain timeline and budget.

Facility Design & Construction Oversight

• Oversee modular cleanroom design, fabrication, delivery, and installation.
• Ensure facility layout supports compliant workflows, material/personnel flows, and environmental controls.
• Coordinate mechanical, electrical, plumbing (MEP), HVAC, HEPA filtration, and critical utility systems (WFI, clean steam, compressed gases, etc.).
• Manage general contractors and subcontractors to ensure compliance with project specifications and cGMP requirements.

Regulatory & Compliance Alignment

• Ensure facility design and build align with Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable FDA guidance.
• Support readiness for FDA inspection and state Board of Pharmacy requirements.
• Collaborate with Quality and Validation teams to ensure proper documentation (URS, FS, DS, IQ/OQ/PQ protocols).
• Ensure adherence to cGMP standards and applicable USP chapters (e.g., USP , ).

Validation & Commissioning

• Oversee commissioning and qualification activities for cleanrooms and critical systems.
• Coordinate environmental monitoring setup and validation activities.
• Support process simulation activities for sterility assurance.
• Support development of SOPs related to facilities and equipment.
• Ensure successful facility turnover to Manufacturing and Quality teams.

Budget & Reporting

• Manage capital expenditure budget and vendor contracts.
• Track project performance metrics and provide regular executive-level updates.
• Ensure change control processes are followed for scope, schedule, and budget modifications.

Required Qualifications

• 7+ years of project management experience in pharmaceutical, biotech, or sterile compounding environments.
• Demonstrated experience leading construction or expansion of GMP-regulated manufacturing facilities.
• Direct experience with cleanroom builds (ISO 7/8 and higher classification preferred).
• Strong knowledge of FDA cGMP regulations and 503B outsourcing facility requirements.
• Experience managing modular construction projects preferred.
• Advanced proficiency with MS Project and/or other project management software.
• Proven ability to manage multi-vendor, cross-functional projects with aggressive timelines.
• Bachelor’s degree in Engineering, Construction Management, Life Sciences, or related field (PMP certification preferred).

Preferred Experience

• Prior experience building or remediating a 503B outsourcing facility.
• Experience preparing facilities for FDA inspection.
• Familiarity with Charleston, SC permitting and construction environment.
• Background in sterile injectable manufacturing.

Key Competencies

• Strong leadership and stakeholder management skills
• Excellent organizational and documentation practices
• Risk-based decision-making approach
• Detail-oriented with strong compliance mindset
• Ability to work on-site in Charleston, SC for critical phases

Deliverables

• Completed modular cleanroom facility delivered on time and within budget
• Fully commissioned and qualified GMP-compliant facility
• Inspection-ready documentation package
• Successful transition to operational manufacturing

This contract role offers a unique opportunity to lead the build of a state-of-the-art 503B modular pharmaceutical manufacturing facility from the ground up within an existing building. The ideal candidate thrives in complex, regulated environments and brings both construction execution expertise and deep GMP knowledge.

To apply, please submit your resume and a brief cover letter describing your relevant

Position Summary

We are seeking a highly skilled and detail-oriented Electro Mechanical Assembly Technician to join our manufacturing team. The ideal candidate will have experience assembling complex, multi-faceted assemblies and sub-assemblies in a structured production environment. This role requires strong mechanical aptitude, a deep understanding of assembly hardware and consumables, and a commitment to quality and process control.

Attention to detail, adherence to quality standards, and the ability to work from engineering drawings and work instructions are critical for success in this position.

Key Responsibilities

• Assemble complex mechanical assemblies and sub-assemblies according to engineering drawings, work instructions, and specifications
• Interpret blueprints, BOMs, and assembly documentation
• Verify correct materials, hardware, and components prior to assembly
• Use hand tools, power tools, torque tools, pneumatic tools, and specialty fixtures appropriately
• Install various hardware types including fasteners, rivets, threaded inserts, pins, bushings, fittings, and mechanical components
• Apply proper assembly consumables (adhesives, sealants, thread lockers, lubricants, etc.) per specifications
• Perform in-process inspections and verify dimensional and visual quality requirements
• Maintain traceability and material verification in accordance with quality system requirements
• Document assembly steps and record required production data accurately
• Identify and escalate quality issues or discrepancies
• Maintain a clean, organized, and safe work environment
• Support continuous improvement initiatives within the production process

Required Qualifications

• 2+ years experience in mechanical assembly (manufacturing environment preferred)
• Experience with complex, multi-component assemblies and sub-assemblies
• Strong understanding of mechanical hardware types and proper installation methods
• Knowledge of assembly tools including torque wrenches, drills, presses, and precision measuring tools
• Familiarity with assembly consumables and proper application techniques
• Ability to read and interpret engineering drawings and technical documentation
• Experience working within a quality management system
• Strong attention to detail and commitment to producing high-quality work
• Ability to verify materials and components against documentation
• High mechanical aptitude

Preferred Qualifications

• Experience in aerospace, industrial equipment, or precision manufacturing
• Familiarity with AS9100, ISO 9001, or similar quality systems
• Experience with material traceability and inspection documentation
• Ability to perform basic quality inspections using calipers, micrometers, and gauges
• Experience working with ERP or manufacturing tracking systems

Key Competencies

• Detail-oriented and process-driven
• Quality-focused mindset
• Strong organizational skills
• Ability to work independently and as part of a team
• Strong problem-solving skills
• Dependable and accountable

Physical Requirements

• Ability to stand for extended periods
• Ability to lift up to 50 lbs
• Ability to use hand tools and perform repetitive tasks

Join our team and Be You Be Aptar

Aptar is seeking a Molding Process Technician based in Congers, NY. The primary function of the Molding Process Technician is to operate injection molding equipment in order to successfully meet production demands and quality standards.

As a Molding Process Technician, you will:

• Utilize your mechanical skills to install, remove and adjust Injection Molding machinery and equipment
• Troubleshoot Injection Molding machines, follow process to resolve failures, other problems
• Perform set-up of molds for all mold changes
• Assist in preventative maintenance and repair of molding machines, molds and peripherals (robots)
• Coordinates and sets up machines, robots and other equipment performing necessary tests to ensure company compliance. Trains employees in the correct procedures for operation as needed.
• Perform cleaning and general maintenance tasks
• Maintain a safe work environment following Company’s safety, ISO standards
• Achieve adequate production levels while maintaining the expected product quality
• Ensure molded components meet all product quality criteria including dimensional criteria
• Communicate to supervisor and other technicians and document all technical information and issues
• Participate in reducing the rate of scrap
• Assist in training of employees in proper work methods for safe and efficient performance of job duties.
• Maintain records, files and other documentation pertinent to assignments.

Who we are looking for:

Required Skills:

• 1-3 years of experience working with injection molding equipment including machine adjustment, troubleshooting and mold installation and removal
• Strong mechanical aptitude and mechanical skills.
• Familiarity with automation 6/3 robotics
• General knowledge of plastic materials and processes
• Detail oriented
• Ability to implement and tune all peripherals (6 axis robot, grinder)
• Strong verbal and written communication skills
• Strong Mathematical aptitude
• Ability to read blueprints, use precision measuring/inspection tools
• Effective computer skills, documentation, reporting, file management and web skills
• Ability to work different work shifts
• Continual improvement mindset. Self-Learner, trend of continuous learning
• Ability to work and operate machinery in a Clean Room Environment.
• Physically capable of the required work including but not limited to: Extensive use of manual dexterity, ability to grip, firmly hold, turn and practice strong hand coordination in order to troubleshoot, service and repair industrial equipment and use hand tools to perform the same.
• Ability to regularly stand, walk, and bend during performance of essential job duties. Ability to lift up to 50 pounds.
• Understands and practices safe working procedures. Observes safety rules and policies; brings to managements’ attention any unsafe acts or conditions

Who We are

At Aptar, we leverage insights, design, engineering and science to develop drug and consumer product dosing, dispensing and protection technologies for many of the world’s leading brands. Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Our innovations nasal drug delivery for emergency medicines, precise fragrance applications, mess-free ketchup dispensing for kids, connected technologies that support patients in adhering to their treatments and much more

With manufacturing facilities across North America, Europe, Asia and South America, and a dedicated team of over 13,000 employees in about 20 countries, Aptar is committed to creating impactful innovations for our customers and their consumers.

Our Culture

At Aptar, our success is driven by the individuals who contribute their unique talents and perspectives every day. We believe that when you bring your authentic self to work, we all thrive.

How We Support Our Employees

• An exciting, inclusive and value based working environment
• Award-winning corporate university offering personal development and training opportunities.
• Competitive base salary and performance-based bonus plan.
• Contribute to the communities where we reside.
• Innovative benefits plan which includes: 401k & Retirement Savings plan, vacation, medical, dental, vision, life, disability, pet insurance, wellness plan, and generous paid maternity/paternity leave.

Compensation and Base Annual Pay

In compliance with pay transparency requirements, the salary range for this role is USD $36.00 to USD $45.00 per hour. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Aptar also offers a variety of benefits, including health, life, and disability insurance, 401(k) match and employer retirement savings contribution, flexible spending accounts, EAP, education assistance, parental leave, paid time off, company-paid holidays, and more. The specific programs and options available to an employee may vary depending on location, pay class, or other factors.

Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.

Stay updated on career opportunities by following us on LinkedIn!

This role supports companywide ISO certification efforts by developing, implementing, and maintaining ISO compliant management systems. The ISO Assessor works independently while partnering closely with Quality, EHS, and technical teams across the organization to ensure global compliance and drive continuous improvement.

Day to Day Responsibilities

• Support company wide ISO compliance and certification efforts

• Develop and improve processes and workflows related to global ISO requirements

• Partner with Quality, EHS, and technical teams to implement ISO compliant management systems • Document business processes and identify gaps impacting ISO certification

• Support internal and external ISO audits including ISO 9001, ISO 14001, and ISO 45001

• Track, document, and follow up on audit findings and corrective actions

• Help drive continuous improvement across Quality and EHS management systems

• Provide basic training on management system controls and compliance as needed

Requirements

1. Demonstrated ability to track actions, meet commitments, and close items without repeated prompting

2. Ability to communicate expectations, escalate appropriately, and influence across functions

3. Ability to apply ISO 9001/ 14001/ 45001 requirements with sound professional judgement and write defensible findings

4. Ability to drive alignment across functions through precise audit reports and practical guidance

EHS Manager

Reporting to the Head of EHS and Sustainability, the EHS Manager is responsible for developing, implementing, and managing environmental, health, and safety programs within operations. This role ensures compliance with all relevant regulations and standards, including OSHA, EPA, and ISO certifications (ISO 45001, ISO 14001, and ISO 50001). The EHS Manager will lead initiatives to reduce workplace hazards, enhance safety culture, promote sustainability, and achieve continuous improvement in EHS performance. This position requires close collaboration with cross-functional teams to ensure the successful execution of EHS strategies. This will be achieved while maintaining HellermannTyton's Quality and EHS certifications by supporting all corporate policies, procedures, work instructions, and required documentation.

Responsibilities:

Site EHS Leadership

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• Ensure operational alignment with HellermannTytons's OIMS framework, compliance with NA EHS Policies, ISO 14001, ISO 45001, and ISO 50001 standards, as well as regulations.
  
  
• Support site-specific EHS annual objectives, targets, and KPIs to drive facility performance improvements in EHS, sustainability, and regulatory compliance.
  
  
• Guide plant management on EHS initiatives, ensuring alignment with HellermannTyton's long-term goals of Zero Harm, continuous improvement, and environmental stewardship.
  
  
• Ensure completion of risk management processes, including risk assessments, hazard analysis (HAZOP), job safety analyses (JSA), and control of work (CoW) processes.
  
  

Incident Management and Root Cause Analysis

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• Lead investigations of all incidents, near misses, and environmental releases, ensuring that a thorough root cause analysis is conducted and that corrective and preventive actions are implemented.
  
  
• Oversee and manage the reporting of incidents in accordance with HellermannTyton's incident management protocols, ensuring all regulatory and corporate notifications are timely and complete.
  
  
• Develop lessons learned materials and facilitate knowledge-sharing sessions to prevent recurrence of incidents, embedding a culture of safety and accountability at all levels.
  
  

EHS Continuous Improvement & Auditing

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• Drive continuous improvement initiatives by conducting regular safety audits, management reviews, and inspections, ensuring that the site remains in full compliance with HellermannTyton's
  
  

OIMS, regulatory requirements, and industry best practices.

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• Lead EHS self-assessments and external audits, ensuring that gaps are identified, action plans are developed, and improvements are implemented.
  
  
• Utilize leading and lagging indicators to assess EHS performance, report trends to senior management, and support data-driven recommendations for improvement.
  
  

Emergency Preparedness & Response

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• Manage emergency response plans, including the establishment of emergency response teams, drills, and simulations, ensuring readiness for events such as fires, chemical spills, and natural disasters.
  
  
• Coordinate with local emergency services and regulatory bodies to ensure smooth collaboration in the event of an actual emergency.
  
  
• Regularly review emergency action plans to reflect current facility conditions, regulations, and best practices.
  
  

Other duties:

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• May take on other duties as assigned.
  
  
• May visit other sites take on EHS responsibilities as required.
  
  

Qualifications:

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• Bachelor's degree in Safety Engineering, Occupational Health and Safety, or equivalent experience.
  
  
• 5+ years of experience in safety or environmental management, preferably in a manufacturing or industrial setting.
  
  
• Strong knowledge of OSHA regulations and safety standards.
  
  
• Knowledge and experience of ISO 45001 & 14001.
  
  
• Excellent communication and interpersonal skills.
  
  
• Ability to travel regionally (5%).
  
  
• Flexible with job assignments and responsibilities.
  
  

By applying for a position with HellermannTyton, you understand that should you be made an offer, it will be contingent on your undergoing and successfully completing a background check through the use of our 3rd party supplier. Background checks may include some or all of the following based on the nature of the position: SSN/SIN validation, education verification, employment verification, criminal check, driving history, and drug test. You will be notified during the hiring process of which checks are required by the position.

HellermannTyton Corporation is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08555

Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
• Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
• Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
• Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
• Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
• Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
• Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
• Foster a collaborative, innovative, and compliant culture within program teams.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
• Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
• Ensure compliance with quality management systems and regulatory requirements, where applicable.
• Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
• Drive design control discipline throughout product development, ensuring compliance
• Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
• Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
• Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
• Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
• Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
• Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
• Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target

Key Requirements and Technology Experience:

• Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
• 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
• Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
• Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
• Project Management Professional (PMP) certification not required but is preferred
• Scrum Master and SAFE Agile certification is preferred.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Technical background in electrical, mechanical, or biomedical engineering
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
• Drive for accountability within self and others.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
• Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Direct experience with major test labs and certification bodies for medical electrical equipment standards.
• Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
• Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
• Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
• Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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