Principal Quality Engineer

Medtronic • Grand Rapids, MI

22h • Onsite

About The Position

Responsible for finished medical devices by supporting manufacturing operations and evaluating whether materials and processes comply with product specifications, regulatory requirements, and customer requirements. Coordinates Quality Engineering for medical device components to ensure finished goods and processes meet specifications. Applies Good Manufacturing Practices (GMP) and works with 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).

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). Uses process-improvement methods and statistical tools to improve processes, support development and validation, and make data-driven decisions. Coordinates product lifecycle management activities, oversees quality systems, authors technical documentation, and applies First Time Quality (FTQ) principles to process improvement and strategic initiatives.

The position is located onsite in Grand Rapids, Michigan, 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; 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 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 for finished medical devices and evaluate materials and processes for compliance with product specifications, regulations, and customer requirements.
• Coordinate Quality Engineering for medical device components and ensure finished goods and processes meet specifications.
• Apply GMP 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 facility audits.
• Conduct risk assessments, PHA, and PFMEA.
• Manage non-conformances, complaints, and CAPA.
• Use process improvement tools, including DMAIC, RCA, 5 Whys, Fishbone, and cause mapping.
• Contribute to Business Value Stream Mapping (VSM) initiatives and support process-flow strategy to drive quality excellence and process-compliant stability.
• Coordinate DOE methods for process development and statistical analyses, including Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV.
• Coordinate verification and validation (V&V) protocols, including IQ, OQ, and PQ.
• Use Minitab and Power BI for statistical analysis and data-driven decision-making.
• Coordinate product lifecycle management, including overseeing quality systems and authoring 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
• Employee referral bonus program at the $1,000 level

What This Job Offers

• Job Type: Full-time
• Career Level: Principal