You will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business
Job Summary
You will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) unit.
We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration.
Matching Summary
You will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
Salary
Base: $106,400.00 - $159,600.00; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, HSA, FSA, Life Insurance, Long-term disability, Dependent daycare spending account, Tuition assistance, Simple Steps, 401(k) with match, Paid time off, Paid holidays, ESPP, EAP, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan
Skills & Requirements
Must-have
ISO 13485, ISO 14971, IEC 62304 compliance
Risk management file development
Hazard identification and mitigation
Design validation and verification tracing
Nice-to-have
AI tools working knowledge
Design for Six Sigma practices
Cross-functional team collaboration
Key Requirements
Bachelor's degree in engineering, math, science or technical discipline and minimum of 4+ years of work experience in engineering and/or quality OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality.
Experience in a highly regulated industry, preferably implantable medical devices.
Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HAL, FTA, DFMEA).
Work Rights
Unrestricted US work authorization required for roles below Principal level