Engineering Manager

Medtronic • Cherry Hill, MA

24d • Onsite

About The Position

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.

Requirements

• 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.
• At least three (3) years’ experience with Extrusion and assembly manufacturing.
• At least three (3) years’ experience with 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP.
• At least three (3) years’ experience with PHA, PFMEA, and ISO 14971.
• At least three (3) years’ experience with Non-Conformances and CAPA.
• At least three (3) years’ experience with DMAIC, RCA, 5Whys, Fishbone, and cause mapping.
• At least three (3) years’ experience with DOE and process development.
• At least three (3) years’ experience with Process validation including IQ/ OQ/ PQ.
• At least three (3) years’ experience with Statistical analysis software including Minitab.

Responsibilities

• 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.

Benefits

• 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)
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager