Senior Software Quality Engineer, Design Assurance

Stryker is hiring a Senior Software Quality Engineer, Design Assurance to support our Medical’s Digital Health division and portfolio Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.

Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations:
San Jose, CA;
Orlando, FL;
Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.

• Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development.
• Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria.
• Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation.
• Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices.
• Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes.
• Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards.
• Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions.
• Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision.

• Bachelor’s degree in a science or engineering.
• Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering.

• Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
• Experience working through software lifecycle processes (Agile SAFe/Waterfall).
• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
• Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills.
• Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.
• Proven ability to influence design quality across global, multidisciplinary teams.
• Knowledge from using Application Lifecycle Management /Traceability tools.

87,600.00 to  salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.