Stryker is looking to solve the problem of ensuring software design quality assurance for pre-market new product development projects in the Medical's Digital Health division and portfolio Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD)
Requirements
- 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
- 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
- Knowledge of regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601)
- Experience with 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
Responsibilities
- Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development
- Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria
- Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation
- Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices
- Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes
- Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards
- Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions
Other
- Bachelor’s degree in a science or engineering
- Minimum of 2+ years of experience working in a highly regulated industry
- Travel Percentage: 20%
- Ability to commute to one of the specific facilities as needed
- Ability to work in a hybrid role with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday
