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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.
  • Travel Percentage: 20%
  • Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
  • Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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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