Senior Software Quality Engineer, Design Assurance

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.