Principal Quality Engineer
About The Position
Medtronic, Inc. is hiring a Principal Quality Engineer in Grand Rapids, Michigan. The role supports manufacturing operations and evaluates whether materials, processes, finished medical devices, and components comply with product specifications, regulatory requirements, and customer requirements. The position coordinates Quality Engineering activities to ensure finished goods and processes meet specifications, and applies Good Manufacturing Practices and medical-device regulations, including 21 CFR Part 820 Quality System Regulation, ISO 13485, EU Medical Device Regulation, and State of the Art requirements. The role coordinates and supports facility audits; conducts risk assessments, Preliminary Hazard Analysis, and Process Failure Modes and Effects Analysis; and manages non-conformances, complaints, and Corrective and Preventive Actions. It uses process-improvement methods and statistical tools to support process development, capability analysis, validation, and data-driven decisions. The engineer also contributes to value-stream mapping and process-flow strategy, coordinates verification and validation protocols, and supports product lifecycle management through quality systems and technical documentation. The position is required to be onsite in Grand Rapids at least four days per week. Relocation assistance is not available.
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; alternatively, 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 V&V 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.
- Must work onsite in Grand Rapids, Michigan, at least four days per week.
Responsibilities
- Support manufacturing operations and evaluate materials and processes for compliance 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 government and 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, Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA).
- Manage non-conformances, complaints, and Corrective and Preventive Actions (CAPA).
- Use process-improvement tools, including DMAIC, Root Cause Analysis, 5 Whys, Fishbone, and cause mapping.
- Contribute to Business Value Stream Mapping initiatives and support process-flow strategy to drive quality excellence and process-compliant stability.
- Coordinate Design of Experiments (DOE) and statistical analyses, including process capability (Cpk/Ppk), ANOVA, Gage R&R, Attribute Agreement Analysis, and Test Method Validation (TMV).
- Coordinate verification and validation protocols, including Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ).
- Use Minitab and Power BI for statistical analysis and data-driven decision-making.
- Coordinate product lifecycle management, including oversight of quality systems and authoring technical documentation.
- Apply First Time Quality (FTQ) principles to improve processes and advance 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
