Senior Software Design Quality Engineer

Stryker is hiring a Senior Software Design Quality Engineer to support our Medical’s Digital Health 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; 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.

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 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.

Preferred:  

• 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.

• Knowledge from using Application Lifecycle Management /Traceability tools.