Senior Software Advanced Quality Engineer, R&D - NPD

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

WHO WE ARE

Stryker is seeking to hire a Senior Software AQE to support Sports Medicine’s new product development team.
This role is hybrid, in Greenwood Village, CO with the expectation to come into the office 3 days a week.
Stryker Sports Medicine

KNOW SOMEONE AT STRYKER?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page
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

The Senior Software Advanced Quality Engineer serves a key role for new product development/ R&D team at Stryker Sports Medicine, a pioneer in patient specific SW applications. The Software Design Quality Engineer interfaces with all functions of the business, including marketing, R&D, clinical, regulatory, and operations, ensuring that the products designed meet and exceed customer needs. By turning voice of customer into user needs, evaluating risk of new products, and performing validation labs in simulated use cases with surgeons, nurses, and specialist customers, this Software Design Quality Engineer is focused on building quality into the products we sell.

• Defining User Needs: Help translate voice of customer feedback to design user needs.
• Defining Functional Specifications: Understand how to take a user need to a quantifiable specification (ex. Force, output, time, etc.)
• 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. Analyze and define critical quality attributes for product and process through risk analysis techniques.
• Cybersecurity Risk Assessment: Identify and analyze potential cybersecurity risks to offer design recommendations to minimize cybersecurity risks. Collaborate closely with SW Systems and Development Engineers leverage software architecture.
• 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).
• Design Reviews: Presents designs for peer review to improve the quality of a design and share best practices.
• Project Documentation: Key reviewer of project documentation relating to design, compliance, and product testing. Final approver on product launch documentation, sending request to senior management to approve product release for sale.
• 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.
• Design Transfer: Support product design transfers to internal and/or external manufacturing facilities.