Medical Devices Engineering Manager — QA & Manufacturing

CVS Covidien Sales LLC; Danvers (MA); On-site; USD 178,000 - 213,000; Full time

Job summary

Medtronic in Danvers, MA seeks a senior Quality/Validation Engineer to plan, direct and implement the design and development of new medical device products. You will establish QA/QC systems and quality controls across extrusion and assembly, ensuring materials, processes and products meet stringent standards.

You will lead risk assessments, CAPA, and process improvements while navigating 21 CFR Part 820, ISO 13485, EU MDR, and GMP in a collaborative, cross-functional team environment.

Qualifications

• Master’s or Bachelor’s in engineering with 3–5 years in medical device quality/validation.
• Experience with 21 CFR Part 820, ISO 13485, EU MDR, GMP.
• Experience with CAPA, non-conformances, and risk management (ISO 14971).

Responsibilities

• Plan, direct and implement design and development of new medical device products.
• Maintain QA/QC systems and processes for extrusion and assembly.
• Lead risk assessments including PHA, PFMEA and ISO 14971.
• Manage CAPA and non-conformances; drive process improvements.

Skills

Extrusion and assembly manufacturing

Quality systems (QSR ISO 13485 GMP)

PHA, PFMEA, ISO 14971

DMAIC, RCA, 5Whys

DOE and process development

IQ/OQ/PQ validation

Minitab statistics

Education

Master’s degree in Mechanical, Industrial, or Biomedical Engineering

Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering

Tools

Minitab

Job description

Medtronic in Danvers, MA seeks a senior Quality/Validation Engineer to plan, direct and implement the design and development of new medical device products. You will establish QA/QC systems and quality controls across extrusion and assembly, ensuring materials, processes and products meet stringent standards.

You will lead risk assessments, CAPA, and process improvements while navigating 21 CFR Part 820, ISO 13485, EU MDR, and GMP in a collaborative, cross-functional team environment.