Principal Quality Engineer
About The Position
The Principal Quality Engineer at Medtronic, Inc. is responsible for finished medical devices, supporting manufacturing operations and evaluating whether materials and processes comply with product specifications, regulatory requirements, and customer requirements. The role coordinates Quality Engineering for medical device components and ensures finished goods and processes meet specifications. The position applies Good Manufacturing Practices (GMP) and relevant government and medical-device regulations, including 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State of the Art (SOTA). It coordinates and supports internal and external facility audits; conducts risk assessments, Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA); and manages non-conformances, complaints, and Corrective and Preventive Actions (CAPA). The engineer uses process improvement methods and statistical tools to improve quality and process stability. These include DMAIC, Root Cause Analysis (RCA), 5 Whys, Fishbone, cause mapping, Value Stream Mapping (VSM), Design of Experiments (DOE), process capability analysis (Cpk/Ppk), ANOVA, Gage R&R, Attribute Agreement Analysis, and Test Method Validation (TMV). The role also coordinates verification and validation protocols, including IQ, OQ, and PQ; uses Minitab and Power BI for statistical analysis and data-driven decisions; supports product lifecycle management, quality systems, and technical documentation; and applies First Time Quality (FTQ) principles. The position is onsite in Grand Rapids, Michigan, at least four days per week. Relocation assistance is not available. The anticipated application window closes December 31, 2026.
Requirements
- Master’s degree in Biomedical, Mechanical, or Industrial Engineering, Engineering Management, or a related engineering field, and five years of experience as a Quality or Packaging Engineer or in a related quality-engineering occupation; OR a bachelor’s degree in one of those fields and seven years of such experience.
- At least five years of experience with GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR or its predecessor, and SOTA.
- At least five years of experience with risk assessments, PHA, and PFMEA.
- At least five years of experience with non-conformances and CAPA.
- At least five years of experience with DMAIC, RCA, 5 Whys, Fishbone, cause mapping, and VSM.
- At least five years of experience with DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV.
- At least five years of experience with Lean–Six Sigma.
- At least five years of experience with verification and validation protocols and IQ/OQ/PQ.
- At least five years of experience with Minitab and Power BI.
- At least five years of experience with product lifecycle management, including quality systems and authoring technical documentation.
- At least five years of experience with FTQ principles.
- Ability to work onsite in Grand Rapids, Michigan, at least four days per week.
Responsibilities
- Support manufacturing operations for finished medical devices and evaluate compliance of materials and processes with product specifications, regulatory requirements, and customer requirements.
- Coordinate Quality Engineering for medical device components and ensure finished goods and processes meet specifications.
- Apply GMP standards and navigate applicable medical-device regulations, including 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA.
- Coordinate and support internal and external audits at the facility.
- Conduct risk assessments, PHA, and PFMEA.
- Manage non-conformances, complaints, and CAPA.
- Use process-improvement methods including DMAIC, RCA, 5 Whys, Fishbone, and cause mapping.
- Contribute to VSM initiatives and support process-flow strategy to promote quality excellence and process-compliant stability.
- Coordinate DOE methods for process development and statistical analysis of process capability, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV.
- Coordinate verification and validation protocols, including IQ, OQ, and PQ.
- Use Minitab and Power BI for statistical analysis and data-driven decision-making.
- Coordinate product lifecycle management efforts, including oversight of quality systems and authorship of technical documentation.
- Apply FTQ principles to enhance process improvement and drive strategic initiatives.
Benefits
- Health insurance
- Dental insurance
- 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
- Incentive plans
- 401(k) plan with employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement, subject to IRS earning minimums
- Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums
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What This Job Offers
Job Type
Full-time
Career Level
Principal
