Senior Design Quality Engineer, New Product Development Advanced
Stryker
Summary
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.
Job description
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.)
Requirements
- Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field
- 2+ years of experience in a highly regulated industry
- 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.)
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.