Staff Software Design Quality Engineer

Stryker is hiring a Staff Software Quality Engineer Design Assurance to support our Medicals 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:

• Execute quality assurance activities for new product development within Strykers global Digital Health Portfolio focusing on Acute Care in the Medical Division.

• Collaborate on software design development and validation strategies ensuring documentation aligns with Quality Management Systems compliance requirements.

• Partner with cross-functional teams including marketing R&D clinical regulatory and operations to deliver quality compliant products.

• Oversee risk management using ISO14971 standards to ensure product safety including defining critical quality attributes assessing residual risks and presenting risk/benefit justifications to executive leadership.

• Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA TGA EUMDR IT).

• Engage in design and development activities for both medical and non-medical software including SaMD MDDS and AI/ML solutions.

• Implement standard development practices promoting methodologies like SAFe for mobile and cloud-based solutions to enhance efficiency and compliance.

• Ensure cybersecurity data privacy and interoperability are integrated into digital product design reviewing software artifacts for compliance and traceability.

What you need:

Required:

• Bachelors degree in a science or engineering.

• Minimum of 4 years of professional experience in the highly regulated medical device industry with a focus in one or more of the following areas: Research & Development (R&D) Quality Assurance/Quality Control (QA/QC) Software Engineering or Systems Engineering.

• Proven expertise navigating regulatory frameworks such as FDA 21 CFR Part 820 ISO 13485 and IEC 62304 with direct experience designing developing and maintaining compliant systems and processes.

• Extensive experience supporting Software as a Medical Device (SaMD) Software in a Medical Device (SiMD) or Digital Health and Telehealth solutions ensuring compliance with global regulatory standards and patient safety requirements.

• Proficient in navigating the full software development lifecycle using methodologies such as Agile (including SAFe) and Waterfall.

• Experience with software Failure Modes Effect Analysis (sFMEA) Security Risk Assessments and defect management software verification/validation.

• Experience with software technologies across mobile cloud and AI/ML domains including development and deployment on iOS and Android devices as well as platforms such as Amazon AWS Microsoft Azure and Apple ecosystems.

Preferred:

• Bachelors degree in Computer Engineering Electrical Engineering Software Engineering or Computer Science.

• Cybersecurity certification (e.g. CISSP Security or equivalent) or demonstrated experience in secure software development with a strong foundation in risk management methodologies and the creation and maintenance of detailed Failure Modes and Effects Analyses (FMEAs).

100500.00 to 215300.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.