Job Description
Posted Wednesday, May 28, 2025, 1:00 AM

JOB SUMMARY:

Quality Assurance Engineers work with design teams to ensure that electronic and software subsystems incorporated into medical devices are designed in accordance with product requirements and the devices meet their intended use. They develop and perform verification and validation activities on medical devices and medical device systems. Verification testing may involve GUI testing, black-box system testing, environmental testing, requirements based functional testing and low-level hardware testing and fault simulation.
Senior Development QA Engineers have extensive/broad knowledge, use creativity to solve complex issues, and contribute to project planning. They have demonstrated leadership and communication skills that contribute to customer confidence and satisfaction. Additionally, they may act as a QA Representative on assigned projects and assist supervising junior engineers and technicians. Senior Development QA Engineers also maintain an effective Quality System, including compliance with US and ISO 13485 design control requirements to support product clearance/approvals/licenses and qualification of quality systems.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s Degree/Technical Degree in Engineering or equivalent experience
• 4-8 years’ experience in a Medical Device manufacturing/product development environment
• Working knowledge of FDA QSR’s, ISO 13485, and ISO 14971 requirements
• Experience/knowledge with product/process verifications/validations
• Experience with DFMEA’s, PFMEA’s and Risk Management
• Must possess good project management skills and initiative in taking on and completing projects
• Must possess good verbal and written communication skills
• Must be able to manage and prioritize multiple projects/objectives
• Strong interpersonal, teamwork, and communication skills.
• Strong written communication demonstrating the ability to simplify complex information.
  The salary range for this position is: $100,000-$125,000. Actual compensation within the range will be dependent upon the individual’s skills, experience, qualifications and location, and applicable employment laws. Beyond base salary, Minnetronix offers a competitive Total Rewards package. We offer health, dental, and vision benefits, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance

• Responsible for creating Design Verification Plan, Risk Management Plan and report, and Compliance Reports
• Audit Test Execution Management, Device Testing, Dry Run Status, Stage Build Process Compliance, and Safety/EMC Test Reports
• May assist in the execution of verification test procedures.
• Ensuring verification configurations tested are production equivalent.
• Review/Approve regression analysis, Trace Matrix, ECOs, DBRs, DV Tool Qualifications, Test Procedures
• 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 Phase Reviews (Phase 1, 2, and 3)
• Monitor project activities to ensure following Minnetronix Standard Operating Procedures and Best Practices.
• Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.