Senior Design Quality Engineer, New Product Development Advanced

Stryker • Flower Mound, TX

4d • Hybrid

About The Position

Stryker is seeking a Senior Design Quality Engineer – NPD Advanced to join its Communications Quality Assurance team. The role focuses on new product development across surgical lights, tables, and booms, helping ensure products meet quality standards and support patient safety and surgical efficiency from concept through commercialization. The position is based in Flower Mound, Texas, and is hybrid or onsite. The role involves partnering with customers and engaging directly with operating-room users to understand their needs and challenges and translate those insights into product solutions. Travel is 20%. The listed annual pay range is $85,500–$142,500 USD, with location-specific ranges available in the U.S. work location and transparency guide.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or a related field.
• At least 2 years of experience in a highly regulated industry.

Nice To Haves

• 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.

Responsibilities

• 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 to support successful product launches.
• Prepare and maintain quality documentation for regulatory submissions and product approvals.
• Conduct risk/benefit analyses and present findings to executive leadership.
• Apply statistical tools and problem-solving techniques to improve product and process performance.
• Oversee design transfers to manufacturing sites and review and approve inspection plans and drawings.
• Mentor junior engineers and use market feedback and prior product issues to inform design improvements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior