Medical Device Quality Engineer II — Design & Verification

Forj Medical; Saint Paul (MN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K plan

Annual bonus

Job summary

Forj Medical is seeking a Design and Development Quality Engineer II in Minnesota to drive project quality across devices and systems. You will support verification/validation activities, ensure SOP-compliant processes, and collaborate with cross-functional teams to deliver safe, compliant medical products.

The role requires a engineering degree and 3–5 years in a medical device environment, with knowledge of FDA QMSR, ISO 13485, IEC 60601, and IEC 62304.

Qualifications

• Bachelor’s Degree in Engineering or equivalent experience.
• 3–5 years in a medical device manufacturing/product development environment.
• Understanding of FDA QMSR, ISO 13485, IEC 60601, IEC 62304 requirements.
• Experience with product/process verifications/validations.
• Experience with DFMEAs, PFMEAs, Risk Management, Equipment Qualifications, and Statistical analysis.

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 adherence to Forj Medical processes.
• Collaborates with Supplier Quality to qualify new suppliers and components.
• Supports teammates in resolving constraints and issues.
• Reviews/approves regression analysis, trace matrices, ECOs, DBRs, tool qualifications, test procedures.
• Manages and monitors DDF files and verification reports.
• Monitors test execution, device testing, and safety/EMC test reports.
• Drives design change assessments with cross-functional support.
• Assists in verification test procedures.

Skills

Bachelor’s degree in engineering

3–5 years experience in medical device

FDA QMSR / ISO 13485 / IEC 60601 / IEC

Education

Bachelor’s Degree in Engineering

Tools

Statistical analysis

Job description

Forj Medical is seeking a Design and Development Quality Engineer II in Minnesota to drive project quality across devices and systems. You will support verification/validation activities, ensure SOP-compliant processes, and collaborate with cross-functional teams to deliver safe, compliant medical products.

The role requires a engineering degree and 3–5 years in a medical device environment, with knowledge of FDA QMSR, ISO 13485, IEC 60601, and IEC 62304.