Senior NPD Design Quality Engineer - Medical Devices(Hybrid)

Regulatory Jobs; 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

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.