Stryker is hiring a Staff Software Quality Engineer, Design Assurance to support its 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.
Requirements
- Experience working through software lifecycle processes (Agile SAFe/Waterfall).
- Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software 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.
- Experience with software technologies for mobile, cloud, and AI/ML solutions, including Amazon AWS, Microsoft Azure, Apple, or Android platforms
- 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).
Responsibilities
- Execute quality assurance activities for new product development within Stryker's 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.
Other
- Bachelor’s degree in a science or engineering.
- Minimum of 4 years of experience working in a highly regulated industry in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineerin
- 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.
- Travel Percentage: 20%
- 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.
