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Senior Design Quality Engineer, New Product Development Advanced

Stryker
Flower Mound, USA
Full-time
Senior · 2+ years experience
Onsite
USD 85500-142500 / year
Discovered 4 days ago

Full Job Posting

What you will do

  • Partner with R&D and cross-functional teams to define design requirements and develop robust manufacturing processes.
  • Lead risk management activities and design reviews to ensure product safety, compliance, and risk mitigation.
  • Drive design verification, validation, and user testing efforts to support successful product launches.
  • Prepare and maintain quality documentation to support regulatory submissions and product approvals.
  • Conduct risk/benefit analyses and present findings to executive leadership for informed decision-making.
  • Apply statistical tools and problem-solving techniques to improve product and process performance.
  • Oversee design transfers to manufacturing sites and review/approve inspection plans and drawings.
  • Mentor junior engineers and leverage market feedback and prior product issues to inform design improvements.
  • What you need
  • Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field
  • 2+ years of experience in a highly regulated industry
  • Preferred
  • Prior experience in Design Quality Engineering
  • Strong understanding of core quality engineering concepts
  • Hands-on NPD experience with medical devices and OEM partnerships
  • Knowledge of risk management, design assurance, V&V, and reliability testing
  • Familiarity with medical device regulations (U.S. and international)
  • Experience interacting with regulatory bodies (FDA, TUV, etc.)
  • United States of America Pay Ranges:
  • US10: $85,500 - $142,500 USD Annual
  • View the U.S. work location and transparency guide to find the pay range for your location.

Qualifications

  • Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field
  • Familiarity with medical device regulations (U.S. and international)

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