Senior Design Quality Engineer (Hybrid)

at  Stryker Corporation

WHY ENGINEERING AT STRYKER?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Stryker is seeking a Senior Design Quality Engineer - NPD in San Jose, CA. The Senior Design Quality Engineer - NPD serves a key role in new product development at Stryker Endoscopy, a pioneer in visualization for Minimally Invasive Surgery (MIS). As the market leader in rigid endoscopy, Stryker continues to set the pace in visualization and instrumentation, allowing surgeons to do more and see more in operating rooms all over the world, every day. The Senior Design Quality Engineer interfaces with all functions of the business, including marketing, R&D, clinical, regulatory, and operations, ensuring that the products designed and manufactured at our facility in San Jose, CA continue to meet and exceed customer needs. Whether helping turn voice of customer into user needs, evaluating risk of new products, or performing validation in simulated use cases with our surgeon, nurse, technician, and specialist customers, the Senior Design Quality Engineer is focused on building quality into the products we sell.

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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role

• Defining User Needs: Help translate voice of customer feedback to design user needs.
• Defining Functional Specifications: Translate user needs into quantified specifications.
• Risk Assessment: Work with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed product, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, or performance.
• Benchmarking Designs: Gathers and analyzes data to benchmark and compare the performance of multiple products using specifications or empirical test data.
• Usability / Human Factors Engineering: Identifies areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists).
• Project Documentation: Key reviewer of project documentation relating to design, compliance, and product testing.
• Validation: Create and execute test protocols that ensure our products satisfy user needs in a safe and effective manner.
• Customer Support: May work with customers to help solve technical issues that arise in the field.
• Complaints and User Issue Resolution: Is a technical resource to troubleshoot problems and ensure that customer satisfaction is achieved through issue resolution.
• Customer Interaction: Visits customer sites to observe OR workflow, surgical procedures, and products in use as required to support concept development or issue resolution.