Mechanical Design Quality Engineer – Medical Devices

Stryker Corporation; Portage (MI); On-site; Confidential; Full time

Job summary

Stryker Corporation in Portage, Michigan is seeking a Staff Design Quality Engineer (Mechanical) to support our Medical business, focusing on quality for new product development and cross‑functional collaboration with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory.

You will lead risk management, design verification and validation, process controls, and post‑market quality support through the change control process, and may drive quality improvement projects.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 4+ years of experience in quality, manufacturing, NPD, or engineering.
• Experience in medical device manufacturing preferred.
• Familiarity with ISO 13485 and ISO 14971.
• Data analysis experience (statistical analysis, SPC, sampling, Minitab).
• Knowledge of FMEA, GD&T, tolerance analysis, RCA, and Mistake Proofing.
• Ability to read CAD models, drawings, specs, and inspection requirements.
• Six Sigma and ASQ CSQE certification is a plus.

Responsibilities

• Partner with R&D to ensure designs meet quality requirements for safety and usability.
• Lead risk management activities and develop risk plans and reports.
• Support PPAP planning and supplier communication.
• Lead design verification and validation activities and post‑market quality support.
• Develop and maintain process controls for mechanical components and manufacturing.
• Contribute to design reviews and documentation throughout development.

Skills

Quality engineering

Risk management

Process controls

Statistical analysis

FMEA

GD&T

Minitab

Six Sigma

RCA

CAD reading

Education

Bachelor's Degree in Mechanical Engineering

Tools

Minitab

CAD

GD&T

Job description

Stryker Corporation in Portage, Michigan is seeking a Staff Design Quality Engineer (Mechanical) to support our Medical business, focusing on quality for new product development and cross‑functional collaboration with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory.

You will lead risk management, design verification and validation, process controls, and post‑market quality support through the change control process, and may drive quality improvement projects.