Designer

• Provides technical and quality system guidance related to establishing software requirements.
• Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures.
• Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
• Leads risk evaluation and associated management activities related to software development including Risk assessments (e.g. FMEA), product risk analysis, and mitigation of software issues.
• Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.

Senior Software Design Assurance Engineer, Medical Device

Senior Software Design Assurance Engineer