Senior Software Quality Engineer, Design Assurance

Senior Software Quality Engineer, Design Assurance

Join to apply for the Senior Software Quality Engineer, Design Assurance role at Stryker
. Stryker is hiring a senior engineer to support our Medical Digital Health division and software‑as‑a‑medical‑device (SaMD) portfolio across pre‑market new product development.

This hybrid role requires the candidate to be within commuting distance of one of the following locations:
San Jose, CA;
Orlando, FL;
Portage, MI; or Fort Wayne, IN. In‑office presence is required Monday through Wednesday, with remote work available Thursday and Friday.

• Design and test prototypes and components, applying engineering principles to meet sub‑system requirements.
• Conduct root‑cause analysis and problem‑solving, evaluating solutions against technical and regulatory criteria.
• Translate design inputs into engineering specifications, contributing to component‑level and system‑level architecture and documentation.
• Develop software components, estimate development resources, and lead code reviews to ensure alignment with design standards and best practices.
• Collaborate cross‑functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes.
• Maintain engineering documentation, including Design History Files, in accordance with medical device regulatory standards.
• Apply a strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions.
• Adapt 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 field.
• Minimum of 2+ years of experience in a highly regulated industry, following cGMP and GDP regulations in R&D, QA/QC, software engineering, IT, healthcare IT, or systems engineering.

• Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
• Experience with software lifecycle processes (Agile, SAFe, Waterfall).
• Experience with software Failure Modes and Effects Analysis (sFMEA), security risk assessments, defect management, and software testing/verification/validation.
• Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar.
• Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), including SaMD, SiMD, digital health systems, or telehealth solutions.
• Knowledge of Application Lifecycle Management and traceability tools.

$89,300.00 to $ salary plus bonus eligibility and benefits. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include medical, prescription drug, dental, vision, critical illness, accident, hospital indemnity, personalized healthcare support, well‑being program, and tobacco cessation program. Financial benefits include a Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance.

Stryker offers innovative products in Med Surg, Neurotechnology, Orthopaedics, and Spine that improve patient and healthcare outcomes. Employees may be required to obtain vaccinations as an essential function of certain roles.