Senior Software Quality Engineer, Design Assurance

Job description

Work Flexibility: Hybrid or Onsite Stryker is hiring a Senior Software Design Quality Engineer to support our Medical’s SmartCare division and portfolio Software as a Medical Device (SiMD) 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 or Orlando, FL. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to one of these specific facilities as needed. What you will do: Design software components and system elements, applying strong engineering and design principles to meet sub‑system requirements and support scalable, high‑quality product development. Lead analytical problem‑solving activities, identifying root causes and evaluating design options against technical, user, and regulatory constraints to drive robust solutions. Translate design inputs into clear engineering specifications, contributing to both component‑level and system‑level architecture and high‑quality technical documentation. Develop software modules and contribute to architectural planning, providing effort estimates and facilitating design and code reviews to ensure alignment with quality standards and engineering best practices. Collaborate with R&D, Quality, Regulatory, and Marketing, ensuring design decisions align with product strategy, user needs, and medical device design control requirements. Create and maintain comprehensive engineering documentation, including Design History File elements, ensuring traceability, compliance, and long‑term maintainability. Stay deeply informed about clinical workflows, customer needs, and operational requirements, using this understanding to guide design choices and enhance product usability and safety. Adapt quickly to new tools, systems, and processes, demonstrating initiative, ownership, and the ability to manage priorities effectively with minimal oversight. What you need: Required: Bachelor’s degree in a science or engineering. Minimum of 2+ years of experience working in the areas of Research & Development (R&D), Quality Engineering, Software Quality Engineering, Information Technology, Healthcare IT or Systems Engineering. Proven experience working in either leading technology company or highly regulated industries, ensuring adherence to cGMP, GDP, or relevant compliance standards. Preferred: Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science. Demonstrated ability to operate within various software development lifecycle models, including Agile SAFe or Waterfall. Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation. 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. United States of America Pay Ranges: USN: $89,300 - $148,800 USD Annual US30: $116,100 - $193,400 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. 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.