Senior Design Quality Engineer – Software (Hybrid)

Stryker is hiring a Senior Design Quality Engineer – Software as part of the Endoscopy Quality team in San Jose, CA.  This Design Quality Engineer will maintain our brand of high-quality products by defining User Needs by translating the voice of customer feedback to design user needs and partner with other NPD functions to bring new products (Hardware and Software) from concept to launch.

Workplace Flexibility: Candidate must reside within a commutable distance to San Jose, CA but is expected to be onsite at the facility multiple times/week.

What you will do:

• Define User Needs by translating the voice of customer feedback to design user needs.
• Provide inputs into Software Requirement Specifications and ensure they are testable, unambiguous and cover the full functionality of the code and user needs.
• Conduct Product and Cybersecurity Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed products, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, durability and performance.
• Provide risk assessment for software defects and drive resolution by using a risk-based approach.
• Provide Usability / Human Factors Engineering to Identify areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists).
• Partner closely with R&D to build security and safety into the design code to ensure products are safe and effective for the end user.
• Review code and support debugging issues of moderate complexity. Ensure test cases are clinically relevant and reflect the workflow of the end user.
• Support troubleshooting of problems and ensure that customer satisfaction is achieved through issue resolution.
• Visits customer sites to observe OR workflow, surgical procedures, and products in use as required to support concept development or issue resolution.

What you will need:

Required:

• Bachelor’s degree in science, engineering or related field
• 2+ years of demonstrated proficiency with product design quality or Research & Development (R&D) with software exposure in a highly regulated environment.

Preferred:

• Bachelor’s degree in Computer Science, Software, Computer Engineering, Electrical or Biomedical Engineering with emphasis with software in medical device industry preferred.
• Medical Device New Product Development experience
• Experience with software heavy electromechanical devices
• Familiarity with Software Development Life Cycle Development (IEC 62304), Usability Engineering (IEC 62366), Risk Management (ISO 14971), ISO 13485
• Familiarity or has the ability to interpret software codes such as C, C++, C#, etc.

$111,200.00 - $182,100.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based

on location. Individual pay is based on skills, experience, and other relevant factors.