Senior Design Quality Engineer, New Product Development Advanced

Posted 6 Days Ago
Be an Early Applicant
Flower Mound, TX, USA
In-Office
86K-143K Annually
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Leads design quality activities for advanced new medical device products, including risk management, design reviews, verification and validation, user testing, regulatory documentation, statistical analysis, design transfer, and inspection plan approval. Partners with R&D and cross-functional teams to support safe, compliant product launches, presents risk-benefit findings to leadership, applies market feedback to improvements, and mentors junior engineers.
Summary Generated by Built In
Work Flexibility: Hybrid or Onsite

Stryker is seeking a Senior Design Quality Engineer – NPD Advanced to join our Communications Quality Assurance team. In this role, you’ll focus on new product development (NPD) across our surgical lights, tables, and booms portfolios. You’ll help shape the future of the operating room by ensuring our products meet the highest quality standards—driving patient safety and surgical efficiency from concept to commercialization. This role is Hybrid in Flower Mound, Texas.


Experience the future of the OR: Stryker Communications

We’re driven to improve healthcare by partnering closely with customers and delivering exceptional product launches. You’ll engage directly with users in the OR to understand their needs and challenges, transforming those insights into innovative solutions.


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.

Skills Required

  • Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or a related field
  • At least 2 years of experience in a highly regulated industry
  • Prior experience in Design Quality Engineering
  • Strong understanding of core quality engineering concepts
  • Hands-on new product development experience with medical devices and OEM partnerships
  • Knowledge of risk management, design assurance, verification and validation, and reliability testing
  • Familiarity with U.S. and international medical device regulations
  • Experience interacting with regulatory bodies such as the FDA and TUV

Stryker Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.

  • Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
  • Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
  • Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.

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The Company
HQ: Portage, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.

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