AMVETS Jobs

Job Information

Medtronic Principal Quality Engineer in Billerica, Massachusetts

We anticipate the application window for this opening will close on - 11 Jun 2025

Position Description:

Principal Quality Engineer for Medtronic, Inc located in Billerica, MA. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Navigates the complexities of working in a quality position in the biomedical/medical device industry. Navigates various government and industry regulations to include FDA Quality System Regulation 21 CRF 820 and ISO 9001, ISO 13485. Works to develop and execute protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Special Product and Process Validations, and Test Method Validations (TMV) or Gage R&R. Coordinates Corrective & Preventive Actions (CAPA) using TrackWise or similar QMS software tools, Nonconformance, Change Control, Deviations and Good Manufacturing Practices (GMP). Utilizes various ERP systems such as ProShop, or SAP manufacturing systems. Coordinates FMEA, validation, methodical problem solving, product design & manufacturing engineering. Utilizes Production Part Approval Process (PPAP), Statistical Process Control (SPC) and Acceptance Sampling. Utilizes the Minitab or JMP for data analysis and visualization. *Multiple positions available. #LI-DNI.

Basic Qualifications:

Master's degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field. Requires five (5) years of experience as a Quality Engineer, Manufacturing Engineer, or related. Experience must include five (5) post-Master's experience in each of the following: Biomedical or medical device industry; FDA Quality System Regulation 21 CRF 820, ISO 9001, and ISO 13485; Development protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Special Product and Process Validations, and TestMethod Validations (TMV) or Gage R&R; Corrective & Preventive Actions (CAPA) using TrackWise or similar QMS software, Nonconformance, Change control, Deviations and Good Manufacturing Practices (GMP); Utilizing ProShop, or SAP ERP manufacturing systems; FMEA, validation, methodical problem solving, product design & manufacturing engineering; Design of Experiments (DOE), Production Part Approval Process (PPAP), Statistical Process Control (SPC) and Acceptance Sampling; Utilizing Minitab or JMP data analysis tools.

Worksite location: 880 Technology Park Drive, Billerica, MA 01821

Salary: $130,600 to $174,000 per year

THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com

The following benefits and additional compensation are available to those regular employees who work 20+ hours 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to 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), and 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: Medtronic benefits and compensation plans (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 setting is 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 (https://www.e-verify.gov/employees) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email AskHR@medtronic.com

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

DirectEmployers