Senior Design Quality Engineer - New Product Development Advanced
Senior Design Quality Engineer - New Product Development Advanced
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Job Description
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 youll focus on new product development (NPD) across our surgical lights tables and booms portfolios. Youll help shape the future of the operating room by ensuring our products meet the highest quality standardsdriving patient safety and surgical efficiency from concept to commercialization.
Experience the future of the OR: Stryker Communications
Were driven to improve healthcare by partnering closely with customers and delivering exceptional product launches. Youll 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:
- Bachelors 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.)
Required Experience:
Senior IC
Employment Type
Full-Time
