Senior Design Quality Engineer - New Product Development Advanced
StrykerAbout the role
Senior Design Quality Engineer - New Product Development Advanced
Flower Mound, TX
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.
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.
Work Flexibility: Hybrid. Candidates must reside within a commutable distance to Flower Mound, TX and be able to work onsite several times per week.
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:
Required:
- 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.)
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s