Senior Design Quality Engineer, New Product Development Advanced

Stryker; 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 the Communications Quality Assurance team in Flower Mound, Texas. You will lead design quality activities across new product development for surgical lights, tables, and booms, focusing on patient safety and regulatory readiness.

You will collaborate with R&D, quality, and manufacturing to define design requirements, perform risk analyses, and drive verification and validation through product launches.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field.
• 2+ years of experience in a highly regulated industry.

Responsibilities

• Define design requirements with R&D and cross-functional teams.
• Lead risk management activities and design reviews for safety and compliance.
• Drive design verification, validation, and user testing for launches.
• Maintain quality documentation for regulatory submissions and product approvals.
• Conduct risk/benefit analyses for decision-making with leadership.
• Apply statistical tools to improve product and process performance.
• Oversee design transfers to manufacturing and approve inspection plans/drawings.
• Mentor junior engineers and leverage past issues to inform design improvements.

Skills

Quality engineering principles

Risk management

Design controls

Statistical methods

Education

Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field

Job description

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

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