Senior Design Quality Engineer - Mechanical (Medical)

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

Job summary

Stryker Corporation is seeking a Staff Design Quality Engineer (Mechanical) in Portage, MI to provide quality support for new product development and cross-functional collaboration across R&D, Operations, and Suppliers. Key responsibilities include leading risk management activities, design verification and validation, and PPAP planning while ensuring compliance with ISO 13485 and ISO 14971.

Candidates should have 4+ years in quality or engineering and a strong background in mechanical design

Qualifications

• Bachelor’s degree in Mechanical Engineering or related discipline.
• 4+ years’ experience in quality, manufacturing, new product development, or engineering.
• Preferred experience in medical device/manufacturing industry.
• Familiarity with ISO 13485 and ISO 14971.
• Data analysis experience (statistical analysis, sampling plans, statistical process control, Minitab).
• Advanced quality tools such as FMEA, GD&T, tolerance analysis, RCA, and mistake-proofing.

Responsibilities

• Partner with R&D to ensure mechanical designs meet safety and usability requirements.
• Lead risk management plans, reviews, and implementation of design and process controls.
• Support PPAP planning and communicate PPAP requirements to suppliers.
• Collaborate with Operations and suppliers to implement robust process controls for components and manufacturing processes.
• Contribute to verification and validation through design reviews and final reports.

Skills

Data analysis

Risk management

CAD interpretation

Education

Bachelor’s Degree in Mechanical Engineering

Tools

FMEA

GD&T

Tolerance analysis

Root Cause Analysis

Mistake Proofing/Poke Yoke

Minitab

Job description

Stryker Corporation is seeking a Staff Design Quality Engineer (Mechanical) in Portage, MI to provide quality support for new product development and cross-functional collaboration across R&D, Operations, and Suppliers. Key responsibilities include leading risk management activities, design verification and validation, and PPAP planning while ensuring compliance with ISO 13485 and ISO 14971.

Candidates should have 4+ years in quality or engineering and a strong background in mechanical design