Senior Design Quality Engineer (Mechanical)

Stryker seeks a Senior Design Quality Engineer (Mechanical) in Portage, Michigan to own quality engineering activities for mechanical workstreams in new product development. The role spans risk management, design verification and validation, manufacturing process controls, and supplier coordination across the product lifecycle.

Responsibilities

• Partner with R&D to evaluate mechanical designs against quality and regulatory requirements
• Develop and own risk management deliverables, including risk plans, reviews, and control verification
• Execute design verification and validation activities, including usability testing and final reports
• Coordinate PPAP execution with suppliers and approve manufacturing process documentation
• Develop and implement robust manufacturing process controls with Operations and supplier partners

Requirements

• Bachelor's degree in Mechanical Engineering or related engineering discipline
• 2+ years experience in quality, manufacturing, new product development, or engineering
• Experience in medical device or regulated manufacturing industry preferred
• Working knowledge of ISO 13485 and ISO 14971 standards
• Proficiency with statistical analysis, sampling plans, and SPC tools like Minitab
• Applied knowledge of FMEA, GD&T, tolerance analysis, and root cause analysis
• Ability to read and interpret CAD models, engineering drawings, and specifications

Compensation: $77,700 - $129,500 USD annual