Medical Device Engineering Manager | Quality & Regulatory Lead

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

Benefits offered by this job

Health insurance

Dental and vision insurance

401(k) plan + match

Paid time off

Job summary

Medtronic, located in Danvers, MA, seeks an Engineering Manager to lead design and development of medical device products, oversee QA/QC systems, and manage risk, CAPA, and process improvements. Requires advanced engineering degree and 3–5+ years in quality/validation for medical devices. Competitive salary and comprehensive benefits.

Role emphasizes regulatory compliance with 21 CFR Part 820, ISO 13485, EU MDR, plus DMAIC and DOE for process optimization.

Qualifications

• Master’s or Bachelor’s in engineering with medical devices exp.
• Experience in extrusion and assembly manufacturing for medical devices.
• Knowledge of 21 CFR Part 820, ISO 13485, EU MDR, GMP

Skills

Quality engineering

Regulatory compliance

Process validation

DMAIC

RCA & 5Whys

DOE

Minitab

Education

MS in Mechanical Engineering or Biomedical Engineering

or BS in Mechanical/Industrial/Biomedical Eng with 5+ yrs

Tools

Minitab

Job description

Medtronic, located in Danvers, MA, seeks an Engineering Manager to lead design and development of medical device products, oversee QA/QC systems, and manage risk, CAPA, and process improvements. Requires advanced engineering degree and 3–5+ years in quality/validation for medical devices. Competitive salary and comprehensive benefits.

Role emphasizes regulatory compliance with 21 CFR Part 820, ISO 13485, EU MDR, plus DMAIC and DOE for process optimization.