Senior Mechanical Design Quality Engineer - Medical Devices

Regulatory Jobs; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker Corporation in Portage, Michigan is seeking a Senior Design Quality Engineer (Mechanical) to lead quality activities for defined mechanical workstreams in new product development and collaborate with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory.

You will own risk management deliverables, design verification/validation, PPAP planning, and quality documentation across components and assemblies, with focus on design transfer and post-market support.

Qualifications

• Bachelor’s Degree in Mechanical Engineering or related field.
• 2+ years’ experience in quality, manufacturing, new product development, or engineering.

Responsibilities

• Partner with R&D to evaluate designs against quality requirements for safety, usability, and manufacturability.
• Own risk management deliverables, including risk plans and reports, and verify design/process controls.
• Execute design quality activities across requirements, reviews, drawings, specs, and change control.
• Develop and execute design verification/validation strategies, including usability activities and final reports.

Skills

Quality engineering

Risk management

Education

Bachelor’s Degree in Mechanical Engineering

Tools

Minitab

GD&T

FMEA

Statistical Process Control

Job description

Stryker Corporation in Portage, Michigan is seeking a Senior Design Quality Engineer (Mechanical) to lead quality activities for defined mechanical workstreams in new product development and collaborate with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory.

You will own risk management deliverables, design verification/validation, PPAP planning, and quality documentation across components and assemblies, with focus on design transfer and post-market support.