Senior Design Quality Engineer (Mechanical)

Stryker • Portage, MI

3d • Onsite

About The Position

Stryker is hiring a Senior Design Quality Engineer (Mechanical) in Portage, Michigan, to support its Medical business. The position independently executes and owns quality engineering activities for defined mechanical workstreams within new product development, partnering with cross-functional teams including R&D, Operations, Manufacturing, suppliers, Testing, and Regulatory throughout development.

The role is responsible for quality activities within assigned products, components, or suppliers, including risk management, design verification and validation, process controls, design transfer, and post-market quality support through change control. The engineer may also contribute to and coordinate quality improvement initiatives within the assigned scope.

Requirements

• Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
• At least 2 years of experience in quality, manufacturing, new product development, or engineering.
• Ability to read and interpret CAD models, engineering drawings, specifications, and inspection requirements.

Nice To Haves

• Experience within the medical device or regulated manufacturing industry.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience with statistical analysis, sampling plans, statistical process control, and Minitab.
• Applied knowledge of advanced quality tools such as FMEA, GD&T, tolerance analysis, root cause analysis, and mistake proofing/Poka-Yoke.
• Knowledge of polymer materials, processes, and performance considerations for medical device applications.
• Six Sigma certification or ASQ certification.

Responsibilities

• Partner with R&D to evaluate mechanical product designs against quality requirements for safety, effectiveness, reliability, manufacturability, and usability, and translate customer and market feedback into clear design and quality requirements for assigned workstreams.
• Own risk management deliverables for assigned new product development workstreams, including developing risk management plans and reports, facilitating risk reviews, and verifying the effectiveness of design and process risk controls.
• Execute and coordinate design quality activities across requirements, design reviews, drawings, specifications, inspection methods, design verification and validation, and change control, ensuring objective evidence supports product acceptance.
• Develop and execute design verification and validation strategies and requirements, including usability activities; review protocols and results; and complete final reports with clear, statistically valid conclusions.
• Partner with Operations and suppliers to develop, evaluate, and implement robust manufacturing process controls for assigned mechanical components and assemblies.
• Coordinate product design and quality transfers to internal and/or external manufacturing facilities, including PPAP planning, supplier communication, readiness reviews, and approval of quality documentation.
• Identify and document critical quality attributes within assigned workstreams using risk-based methods and ensure alignment with design outputs and process controls.
• Own PPAP execution for assigned components or suppliers; communicate PPAP requirements to component suppliers, evaluate submission readiness, and approve PPAP documentation and results within the assigned scope.
• Support quality system maintenance and improvement by identifying procedural updates and implementing effective, sustainable solutions.

What This Job Offers

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