Principal Quality Engineer

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