Senior Mechanical Design Quality Engineer (Medical Devices)

Stryker Group; Portage (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker is seeking a Staff Design Quality Engineer (Mechanical) for Portage, Michigan to support the Medical business. You will provide quality support for new product development and partner with cross-functional teams throughout the development process.

You will lead risk management, design validation, and PPAP activities, while collaborating with R&D, Operations, and Suppliers to ensure robust process controls and compliant design outputs.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related engineering discipline.
• 4+ years’ experience in quality, manufacturing, new product development, or engineering.
• Experience in medical device/manufacturing industry (preferred).
• Familiarity with ISO 13485 and ISO 14971 (preferred).
• Data analysis experience (statistical analysis, sampling plans, SPC, Minitab).
• Advanced Quality tools: FMEA, GD&T, tolerance analysis, Root Cause Analysis, Mistake Proofing/Poke Yoke; ability to read CAD models, drawings, specs, and inspection requirements.
• Six Sigma Certification (preferred).
• ASQ CSQE certification (preferred).

Responsibilities

• Partner with R&D to ensure mechanical designs meet quality requirements for safety, effectiveness, reliability, manufacturability, and usability.
• Lead risk management activities for new product development by creating plans and reports and verifying controls.
• Collaborate with Operations and suppliers to implement robust process controls for mechanical components and manufacturing processes.
• Participate in design reviews and track how design features mitigate risks throughout development.
• Lead design validation activities, including human factors usability engineering and evaluation against user needs.
• Support product design and quality transfers to internal and external facilities.
• Analyze and define critical quality attributes for products and processes via risk analysis techniques.
• Contribute to final design verification and validation reports.
• Support PPAP planning and approval with suppliers.

Skills

Quality engineering

Risk management

Design verification & validation

Process controls

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering

Tools

Minitab

CAD software

FMEA

Job description

Stryker is seeking a Staff Design Quality Engineer (Mechanical) for Portage, Michigan to support the Medical business. You will provide quality support for new product development and partner with cross-functional teams throughout the development process.

You will lead risk management, design validation, and PPAP activities, while collaborating with R&D, Operations, and Suppliers to ensure robust process controls and compliant design outputs.