Engineering Manager

## Engineering Manager Postuler:
Danvers, Massachusetts, United States of America:
Temps plein:
Offre publiée aujourd'hui:
Date de fin : 19 novembre 2026 (Il reste plus de 30 jours pour postuler):
R77113

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), 5

Whys, 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, 5

Whys, 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