Engineering Manager
Medtronic
Summary
Engineering Manager for Medtronic, Inc. in Danvers, MA. Plan, direct and implement various aspects of the design and development of new medical device products.
Job description
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.
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.
- 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
- Statistical analysis software including Minitab
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health savings account
- Healthcare flexible spending account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance
- Global well-being program
- Incentive plans
- 401(k) plan
- Short-term disability
- Paid time off
- Paid holidays
- Employee stock purchase plan
- Employee assistance program
- Non-qualified retirement plan supplement
- Capital accumulation plan
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.