Senior Mechanical Design Quality Engineer – Medical Devices

Regulatory Jobs; Portage (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker in Portage, Michigan is hiring a Staff Design Quality Engineer (Mechanical) to support our Medical business. You will partner with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory to drive quality across the development process.

The role emphasizes risk management, design verification and validation, process controls, and post‑market quality support through change control. A Mechanical Engineering degree and 4+ years in quality/NP development are preferred, with

Qualifications

• Bachelor’s degree in Mechanical Engineering.
• 4+ years’ experience in quality, manufacturing, or new product development (NPD).
• Experience in the medical device industry or with ISO standards is a plus.

Responsibilities

• Partner with R&D to ensure mechanical designs meet safety, effectiveness, and usability requirements.
• Lead risk management plans, reviews, and verify risk control effectiveness.
• 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 through development.
• Lead design validation activities including human factors usability evaluation against user needs.

Skills

Quality engineering

Mechanical engineering

Risk management

Design validation

Education

Bachelor’s Degree in Mechanical Engineering

Tools

FMEA

GD&T

Minitab

Root Cause Analysis

Poke Yoke

Job description

Stryker in Portage, Michigan is hiring a Staff Design Quality Engineer (Mechanical) to support our Medical business. You will partner with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory to drive quality across the development process.

The role emphasizes risk management, design verification and validation, process controls, and post‑market quality support through change control. A Mechanical Engineering degree and 4+ years in quality/NP development are preferred, with