IN THIS ROLE YOU

Will support New Product Development and Sustaining projects within Image Guide Therapy with respect to software, firmware, and hardware from a Software Design Quality Assurance perspective.

YOUR ROLE:

• Develop and Review SW Design Verification Plans, Protocol and Reports. Conduct SW Design Verification per SW Design Verification Plan and Protocol. Developing and Reviewing Quality plans.
• Leading and supporting the development, design verification and hypercare of non-product software assessments and qualification efforts.
• Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.
• Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.
• Serving as SME for Software Design Assurance and collaborate with teams on code review, unit tests, software security analysis, defect and vulnerability triage, creation and review of sBOMs, etc. and leading implementation of best practices for software quality processes.