Medical Device Design & Development QA Engineer II

Minnetronix Medical; Saint Paul (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision plans

401K plans

Paid time off

Job summary

Forj Medical in Saint Paul, MN is seeking a Design and Development Quality Engineer II to drive project quality across development activities and ensure processes meet SOPs and regulatory requirements.

You will work under senior QA staff to support verification and validation of medical devices, contribute to DFMEAs/PFMEAs, risk management, and collaboration with suppliers. This full-time role offers growth in a manufacturing environment.

Qualifications

• Bachelor’s or technical degree in engineering or equivalent experience.
• 3–5 years’ experience in a medical device manufacturing/product development environment.
• Understanding of FDA QMSR, ISO 13485, IEC 60601, IEC 62304 requirements.

Responsibilities

• Participates/Approves in development of requirements, technical reviews, test report development, design transfer coordination/support and FMEA, DFMEA development.
• Participates in project/customer meetings and leads phase reviews.
• Monitors project activities to ensure following Forj Medical processes.
• Reviews/Approves regression analysis, Trace Matrix, ECOs, DBRs, DV Tool Qualifications, Test Procedures.
• Drives design change assessments including planning and report documentation with cross functional support.

Skills

Regulatory knowledge

V&V

DFMEA/PFMEA

Project management

Communication

Education

Bachelor’s Degree/Technical Degree in Engineering

Job description

Forj Medical in Saint Paul, MN is seeking a Design and Development Quality Engineer II to drive project quality across development activities and ensure processes meet SOPs and regulatory requirements.

You will work under senior QA staff to support verification and validation of medical devices, contribute to DFMEAs/PFMEAs, risk management, and collaboration with suppliers. This full-time role offers growth in a manufacturing environment.