Staff Quality Engineer, Post Market

Stryker is hiring an Staff Quality Engineer, Post Market in Flower Mound, CA supporting our Endoscopy division to provide technical leadership across product quality, risk management, and continuous improvement initiatives. In this role, you will serve as a key quality subject matter expert, driving complex investigations, leading cross-functional problem-solving efforts, and influencing product and process improvements throughout the product lifecycle. You will partner with engineering, manufacturing, operations, and commercial teams to ensure compliance, enhance product performance, and deliver quality solutions that improve customer and patient outcomes.

What you will do:

• Lead and prioritize multiple product quality and design improvement initiatives, providing technical leadership across complex projects and business-critical issues.

• Serve as a quality and customer advocate by driving urgent customer support, resolving escalated product concerns, and ensuring timely issue resolution.

• Lead complex investigations of customer complaints, leveraging root cause analysis, post-market data, and risk assessments to drive product safety, reliability, and performance improvements.

• Own the development, validation, and implementation of product and design changes, partnering closely with engineering, manufacturing, and suppliers to ensure successful execution.

• Drive software and hardware quality improvements by leading field issue investigations, supporting defect resolution, and influencing release strategies to address customer needs.

• Analyze and trend quality, reliability, and post-market surveillance data to identify emerging risks, inform decision-making, and drive proactive continuous improvement initiatives.

• Partner directly with customers and clinical stakeholders through field observations and site visits to understand product use, workflow challenges, and opportunities for innovation.

• Provide technical mentorship and quality leadership across the organization while supporting Quality Systems activities, new product development efforts, and strategic business initiatives, including acquisitions.

What you need:

Required Qualifications 

• Bachelor's degree in Engineering  or related

• Minimum of 4+ years of experience in engineering, design, quality, usability/human factors, or related 

Preferred Qualifications 

• Engineering degree in Electrical, Computer Science, Software, or Biomedical Engineering with a heavy emphasis on Electrical or Software  

• 4-7 years of related experience in R&D/design, design assurance, usability/human factors, quality, systems engineering 

• Hands-on design experience with software or hardware 

• Root cause analysis and troubleshooting experience 

• Familiarity with ISO 14971, ISO 13485, ISO 60601, ISO 62366, and/or ISO 62304 

• Commitment to excellence and high standards. 

• Excellent written and oral communication skills. 

• Strong organizational, problem-solving, root cause and analytical skills. 

• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. 

• Proven ability to handle multiple projects and meet deadlines. 

• Good judgment with the ability to make timely and sound decisions. 

• Acute attention to detail.