Engineering Manager

Position Description:

Engineering Manager for Medtronic 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:

Masters 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 Bachelors 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: $178000 to $213000 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:

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