Base: $149,500 to $187,200 py; bonus/equity: incen...
Onsite
Mechanical gd&t and rca
Fda 21 cfr part 820
Iso 13485, iso 9001
Responsible for providing quality engineering support to ensure the successful development of Medtronic medical products, meeting design control requirements and applicable industry standards
Job Summary
Responsible for providing quality engineering support to ensure the successful development of Medtronic medical products, meeting design control requirements and applicable industry standards.
Update risk management documents, utilize Mechanical GD&T and RCA, and navigate government and industry regulations including FDA 21 CFR Part 820 and ISO standards.
The position offers a competitive salary range and a comprehensive benefits package including health insurance, retirement plans, and paid time off.
Matching Summary
Responsible for providing quality engineering support to ensure the successful development of Medtronic medical products, meeting design control requirements and applicable industry standards.
Salary
Base: $149,500 to $187,200 per year; Bonus/Equity: Incentive plans, 401(k) plan plus employer contribution and match, Employee Stock Purchase Plan, Capital Accumulation Plan; Benefits: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, Simple Steps (global well-being program), Short-term disability, Paid time off, Paid holidays, Employee Assistance Program, Non-qualified Retirement Plan Supplement
Skills & Requirements
Must-have
Mechanical GD&T and RCA
FDA 21 CFR Part 820
ISO 13485, ISO 9001
Risk analysis and FMEA
Verification and validation (V&V)
Design of Experiments (DOE)
Nice-to-have
Methodical problem solving
Lean Six Sigma, GMP, GDP
Support regulatory audits
Key Requirements
Master's degree in Mechanical or Biomedical Engineering
Five (5) years of experience as a quality or manufacturing engineer
Minimum of five (5) years of experience in specific technical areas and regulatory standards