Senior Design Quality Engineer (Software/Electrical)

Stryker · Portage, MI

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QualityFull-time$78k–$130kCompany career page

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Role summary

Senior Design Quality Engineer supporting medical device development at an acute care company. The role involves partnering with cross-functional teams to ensure software and electrical designs meet quality, safety, and regulatory standards throughout product development and launch.

What they're looking for

Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science, or related discipline
2+ years experience in quality, manufacturing, new product development, or engineering field
Medical device or manufacturing industry experience preferred
Knowledge of ISO 13485 and ISO 14971 standards preferred
Experience with design controls, verification, validation, or cybersecurity activities preferred
Ability to read electrical schematics and technical specifications

What you'll be doing

Partner with R&D to ensure designs meet quality, safety, reliability, manufacturability, and cybersecurity requirements
Lead risk management activities including risk planning, reviews, and verification of control effectiveness
Support design validation and verification activities including human factors usability engineering
Collaborate on cybersecurity implementation and security requirement verification
Support product design transfer to manufacturing and supplier PPAP planning

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