Engineering Manager Medtronic - 3.8 Danvers, MA Job Details Full-time $178,000 - $213,000 a year 7 hours ago Benefits Health savings account Employee stock purchase plan Paid holidays Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Paid sick time Qualifications Incident investigation techniques for hazard identification Conducting hazard assessments Defect resolution root cause analysis Medical law ISO standards Quality control statistical data analysis Preventive action implementation Design of experiments Production deviation management Six Sigma methodology implementation Engineering process optimization Corrective and preventive actions (CAPA) GMP Minitab Assembly Extrusion machines Policy & process development Production validation processes Quality risk management Medical device manufacturing facility experience Biomedical regulatory compliance Biomedical manufacturing processes Quality improvement programs in engineering Product quality failure FDA regulations Statistical analysis tools Failure analysis Full Job Description We anticipate the application window for this opening will close on - 19 Nov 2026

Position Description:

Engineering Manager for Medtronic, Inc. in Danvers, MA. 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

; and Statistical analysis software including Minitab.

Salary:

$178,000 to $213,000 per year 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: https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic

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