Define User Needs by translating the voice of customer feedback to design user needs. Partner with other NPD functions to bring new products (Hardware and Software) from concept to launch. 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 wi... more details
Work Flexibility: 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.
Who we want:
Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
Challengers & Influencers. People who constantly challenge themselves and each other to achieve more & to win the right way.
Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.
What you will do:
Define User Needs by translating the voice of customer feedback to design user needs.
Partner with other NPD functions to bring new products (Hardware and Software) from concept to launch.
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.
Work with software engineers to ensure that all modules will integrate properly.
Present designs for peer review to improve the quality of a design and share best practices.
Support reviews of project documentation relating to design, compliance, and product testing.
Potentially work with customers to help solve any technical issues that arise in the field.
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:
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.
85,500.00 to 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.
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
