Software Design Assurance Engineer (Hybrid - San Diego, CA)

Software Design Assurance Engineer responsible for driving Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems. This includes ensuring software development process compliance with applicable standards, regulations, and guidance documents for medical devices, including supporting Cyber security development processes and Cyber Bill of Materials.

Requirements

• Lead Design Control and Software Development initiatives
• Ensure compliance to IEC 62304 and FDA Guidance on Software Contained in a 510(k) Submission
• Support efforts for cybersecurity risk management for US and ROW requirements
• Support development teams on the validation of software tools
• Provide guidance for the generation, review and approval of design control documentation
• Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• Additional employee wellness programs