Position: Sr. Consultant with experience in Medical Device validation and 62304 governance standards
Location: San Diego, CA
Length: Long Term.
100% Onsite position
Ensure the quality of the medical device software and hardware meets the design requirements
Ensure design requirements are testable
Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation
Execute protocols/test scripts and document results
Generate and/or update summary reports
Participate in process improvements
Ensure compliance with FDA device regulatory requirements, including DHF and 510(k)