S
Sr Staff Design Quality Engineer
Accepting applicationsStryker · Flower Mound, TX
Full-Time Mid_senior C++Spiaiasicate
Posted
2d ago
Category
Test
Experience
Mid_senior
Country
United States
Sr. Staff Design Quality Engineer – Flower Mound, Texas
You’ll partner with product development teams to deliver design quality for complex electromechanical medical devices and consumables. This role focuses on translating user needs into design requirements, guiding risk and test strategies, and ensuring design documentation and verification align with global medical device standards. You lead technical problem solving, mentor others, and collaborate across functions to advance products through design, development, and launch.
You will support the Urology portfolio, including legacy products and a recently launched product integrating capital equipment, visualization platforms, and fluid management technologies.
What You Will Do
Lead design quality activities for electrical components, subsystems, and system-level designs on complex electromechanical medical devices and consumables.
Support products in the midst of launch and post‑market stabilization, navigating evolving priorities while maintaining design control rigor and risk‑based decision making.
Translate user needs into design inputs/specifications and maintain traceability through design outputs, verification, and validation deliverables.
Define and execute advanced prototyping, test methods, and verification strategies aligned to applicable standards (e.g., IEC 60601, IEC 62304) and project plans.
Identify and resolve complex product design issues by driving root cause investigations, design tradeoff decisions, and design changes with documented rationale.
Create and refine regulated design documentation (including Design History File content) and mentor teams on good documentation practices and required technical evidence.
Apply and coach risk management, corrective and preventive action, audit readiness, and statistical methods within design and development activities.
Partner with cross-functional stakeholders (Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management) to plan and deliver design reviews, milestones, and release readiness.
Support direct customer and surgeon engagement, including voice‑of‑customer activities, field feedback, and quality events or complaints tied to design or usability, translating real‑world use into design improvements.
Required
What you will need
Bachelor’s degree in Science, Engineering, or a related discipline.
Minimum 6 years of experience in medical device product development and/or design quality engineering.
Experience working within highly regulated industries with formal quality systems and design documentation practices (e.g., ISO 13485 or comparable industry standards).
Experience with design controls, risk management, and verification/validation planning for electro‑mechanical products.
Preferred
A master’s degree in a relevant discipline and certifications such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Green or Black Belt
Experience supporting new product launches and post‑market design improvements for complex electromechanical medical devices and consumables
Experience with medical device design and software lifecycle standards (e.g., IEC 60601, IEC 62304).
Hands‑on experience evaluating and testing:
Software code (C, C++, C#)
Electronic designs, including printed circuit board assemblies and subsystems
Mechanical designs and technical drawings
US10: $129,800 - $216,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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You’ll partner with product development teams to deliver design quality for complex electromechanical medical devices and consumables. This role focuses on translating user needs into design requirements, guiding risk and test strategies, and ensuring design documentation and verification align with global medical device standards. You lead technical problem solving, mentor others, and collaborate across functions to advance products through design, development, and launch.
You will support the Urology portfolio, including legacy products and a recently launched product integrating capital equipment, visualization platforms, and fluid management technologies.
What You Will Do
Lead design quality activities for electrical components, subsystems, and system-level designs on complex electromechanical medical devices and consumables.
Support products in the midst of launch and post‑market stabilization, navigating evolving priorities while maintaining design control rigor and risk‑based decision making.
Translate user needs into design inputs/specifications and maintain traceability through design outputs, verification, and validation deliverables.
Define and execute advanced prototyping, test methods, and verification strategies aligned to applicable standards (e.g., IEC 60601, IEC 62304) and project plans.
Identify and resolve complex product design issues by driving root cause investigations, design tradeoff decisions, and design changes with documented rationale.
Create and refine regulated design documentation (including Design History File content) and mentor teams on good documentation practices and required technical evidence.
Apply and coach risk management, corrective and preventive action, audit readiness, and statistical methods within design and development activities.
Partner with cross-functional stakeholders (Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management) to plan and deliver design reviews, milestones, and release readiness.
Support direct customer and surgeon engagement, including voice‑of‑customer activities, field feedback, and quality events or complaints tied to design or usability, translating real‑world use into design improvements.
Required
What you will need
Bachelor’s degree in Science, Engineering, or a related discipline.
Minimum 6 years of experience in medical device product development and/or design quality engineering.
Experience working within highly regulated industries with formal quality systems and design documentation practices (e.g., ISO 13485 or comparable industry standards).
Experience with design controls, risk management, and verification/validation planning for electro‑mechanical products.
Preferred
A master’s degree in a relevant discipline and certifications such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Green or Black Belt
Experience supporting new product launches and post‑market design improvements for complex electromechanical medical devices and consumables
Experience with medical device design and software lifecycle standards (e.g., IEC 60601, IEC 62304).
Hands‑on experience evaluating and testing:
Software code (C, C++, C#)
Electronic designs, including printed circuit board assemblies and subsystems
Mechanical designs and technical drawings
US10: $129,800 - $216,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Show more Show less