Senior Design Quality Engineer, New Product Development Advanced

Regulatory Toolkit; Flower Mound (TX); Hybrid; USD 86,000 - 143,000; Full time

Job summary

Stryker is seeking a Senior Design Quality Engineer – NPD Advanced to join our Communications Quality Assurance team in a Hybrid role in Flower Mound, Texas. You’ll drive design activities across surgical lights, tables, and booms to ensure product safety and regulatory compliance.

Join a team focused on delivering high-quality product launches and leveraging user feedback to inform improvements. Travel ~20% may be required as part of the role.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field.
• 2+ years of experience in a highly regulated industry.
• Experience with design quality engineering concepts preferred.

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 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.

Skills

Quality engineering

NPD experience

Medical devices

Regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

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.