Engineering Manager

CVS Covidien Sales LLC; Danvers (MA); On-site; USD 178,000 - 213,000; Full time

Job summary

Medtronic in Danvers, MA seeks a senior Quality/Validation Engineer to plan, direct and implement the design and development of new medical device products. You will establish QA/QC systems and quality controls across extrusion and assembly, ensuring materials, processes and products meet stringent standards.

You will lead risk assessments, CAPA, and process improvements while navigating 21 CFR Part 820, ISO 13485, EU MDR, and GMP in a collaborative, cross-functional team environment.

Qualifications

• Master’s or Bachelor’s in engineering with 3–5 years in medical device quality/validation.
• Experience with 21 CFR Part 820, ISO 13485, EU MDR, GMP.
• Experience with CAPA, non-conformances, and risk management (ISO 14971).

Responsibilities

• Plan, direct and implement design and development of new medical device products.
• Maintain QA/QC systems and processes for extrusion and assembly.
• Lead risk assessments including PHA, PFMEA and ISO 14971.
• Manage CAPA and non-conformances; drive process improvements.

Skills

Extrusion and assembly manufacturing

Quality systems (QSR ISO 13485 GMP)

PHA, PFMEA, ISO 14971

DMAIC, RCA, 5Whys

DOE and process development

IQ/OQ/PQ validation

Minitab statistics

Education

Master’s degree in Mechanical, Industrial, or Biomedical Engineering

Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering

Tools

Minitab

Job description

Position Description

Plan, direct and implement various aspects of the design and development of new medical device products. Develop, evaluate, implement and maintain technical quality assurance and control systems standards in extrusion and assembly manufacturing pertaining to materials, techniques, and products. Select, develop and evaluate personnel to ensure the efficient operation of the function. Leverage Quality Engineering for medical device components meeting specifications. Navigate government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), State of the Art (SOTA) and Good Manufacturing Practices (GMP). Manage Risk Assessments including Preliminary Hazard Analysis (PHA), Process Failure Mode Effect Analysis (PFMEA) and ISO 14971 Risk Mgmt. for Medical Devices. Manage the Non‑Conformances, Complaints and Corrective and Preventive Actions (CAPA). Leverage Process Improvement Tools including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5Whys, Fishbone and cause mapping. Leverage Design of Experiments (DOE) methods to establish process development and Minitab for statistical analysis. Manage product validation to include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Implement inspection optimization improvement projects. Relocation assistance is not available for this position. #LI‑DNI.

Basic Qualifications

• Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and three (3) years of experience as a quality/validation engineer or related occupation in quality engineering for medical devices
• or alternatively, Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a quality/validation engineer or related occupation in quality engineering for medical devices.
• Must possess at least three (3) years’ experience with each of the following:
  • Extrusion and assembly manufacturing
  • 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP
  • PHA, PFMEA, and ISO 14971
  • Non‑Conformances and CAPA
  • DMAIC, RCA, 5Whys, Fishbone, and cause mapping
  • DOE and process development
  • Process validation including IQ/ OQ/ PQ
  • Statistical analysis software including Minitab

Salary

Salary: $178,000 to $213,000 per year

Benefits for Regular Employees (20+ hrs per week)

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long‑term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well‑being program)

Benefits for All Regular Employees

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short‑term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non‑qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns.

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people.

That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA.

Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning.

These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here.