Engineering Manager

Medtronic plc; Danvers (MA); On-site; USD 178,000 - 213,000; Full time

Job summary

Medtronic plc recherche un Engineering Manager à Danvers, MA, pour diriger le développement de nouveaux dispositifs médicaux et garantir la conformité aux normes QMS (21 CFR Part 820, ISO 13485, MDR). Vous supervisez la conception, les essais, l’évaluation des risques et les CAPA, tout en optimisant les processus avec DMAIC et DOE, et vous vous appuyez sur Minitab pour les analyses.

Ce poste exige une expérience approfondie en extrusion et assemblage, la maîtrise des cadres réglementaires et la

Qualifications

• Diplôme requis: Master ou Bachelor en ingénierie mécanique/industrielle/biomédicale avec expérience en ingénierie qualité pour dispositifs médicaux.

Responsibilities

• Planifier, diriger et mettre en œuvre divers aspects de la conception et du développement de nouveaux dispositifs médicaux.
• Évaluer et maintenir les systèmes de contrôle qualité et assurance qualité conformes à 21 CFR Part 820, ISO 13485 et MDR.
• Gérer les risques via PHA, PFMEA et ISO 14971; CAPA et non-conformances.
• Utiliser DMAIC, RCA et DOE et réaliser des analyses statistiques (Minitab).
• Valider les produits (IQ/OQ/PQ) et optimiser l’inspection.

Skills

DMAIC

RCA

5Whys

Fishbone

Cause mapping

DOE

PHA

Minitab

Statistical analysis

Education

Master’s degree in Mechanical/Industrial/Biomedical Engineering

Bachelor’s degree in Mechanical/Industrial/Biomedical Engineering

Tools

Minitab

Job description

## Engineering ManagerPostuler: 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): R77113We 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