Stryker Corporation-posted about 1 month ago
Full-time • Mid Level
Hybrid • Portage, MI
5,001-10,000 employees
Miscellaneous Manufacturing

Join one of the world's leading medical technology companies and help shape the future of healthcare. As a Senior Design Quality Engineer, you will play a critical role in ensuring our innovative products meet the highest standards of safety and effectiveness-ultimately improving patient outcomes worldwide. Work Flexibility: Hybrid: Candidates must reside within a commutable distance to Portage, MI and be able to work onsite several times per week.

  • Ensure product designs meet quality, safety, and effectiveness requirements by partnering with R&D and cross-functional teams.
  • Lead risk management activities for new product development, including creating plans, conducting reviews, and verifying risk controls.
  • Execute design validation activities, including human factors engineering and usability testing.
  • Collaborate with Product Security and R&D teams to implement cybersecurity best practices in product design.
  • Participate in design reviews and track risk mitigation throughout development and manufacturing processes.
  • Support product design transfers to internal and external manufacturing facilities.
  • Analyze and define critical quality attributes for products and processes using risk analysis techniques.
  • Partner with suppliers and manufacturing to implement robust process controls and quality improvements.
  • Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, Biomedical Engineering, or related field with relevant experience.
  • 2+ years of experience in quality, manufacturing, new product development, software, or engineering.
  • Experience in the medical device or manufacturing industry.
  • Familiarity with ISO 13485 and ISO 14971 standards.
  • Knowledge of statistical analysis tools (e.g., Minitab) and advanced quality tools (FMEA, GD&T, Root Cause Analysis).
  • Experience with Software Development and Connectivity technology such as Wi-Fi, Bluetooth, UWB (ultra wide band)
  • Ability to read and interpret CAD drawings.
  • Six Sigma certification.
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