Manager, Software Validation Engineering (V&V)
Kforce Inc

San Diego, California

This job has expired.


Kforce has a client seeking a Manager of Medical Device Software Validation in San Diego, CA.Summary:A growing Medical Device Company in the San Diego area is seeking a Lead or Manager, Software Validation Engineering (V&V). We are working directly with the Hiring Manager. This role will be responsible for managing the validation of embedded device software, manufacturing applications, and associated software tools. They will also lead in the practice of agile principles, including sprint planning, stand-ups, weekly discussion and etc. Responsibilities:
  • Lead or hands-on Manager; 80% hands on testing and validation of software and software/hardware integration
  • Facilitate daily stand-ups, sprint planning, backlog refinement, sprint goals, plan upcoming releases, sprint review, sprint retrospectives, and other related team meetings
  • Create and update software requirements, risk management, cybersecurity, and other software plans and reports
  • Will lead a group of V&V Engineers
  • Validation report and validation summary
  • Manage the validation of device software and associated tools
  • Develop product and process improvements based on software best practices and agile methodology
  • Oversee and evaluate deliverables generated by V&V engineers
  • Create SOWs and track progress of deliverables with external partners
  • Lead/participate in technical reviews and formal stage-gate design reviews
  • Work closely with software development engineers and manufacturing engineers to resolve software issues
  • Participate in compiling and reviewing regulatory submission packages
  • Design and develop V&V plans, COTS Plan, test protocols and procedures, test scripts, test cases, and test fixtures to validate embedded software/firmware in electronic motor control, electroporation, and safety monitoring systems


  • BS degree in Computer Science, Electrical Engineering, or a related field
  • Minimum of 5-10+ years of related experience in V&V medical device software validation experience at the embedded level
  • Experience leading or managing a software validation team and working with external contract vendors
  • Prior experience working with regulatory on submissions of software documents to the FDA
  • Experience in the use of common test equipment (spectrum analyzer, signal generator, oscilloscopes, logic analyzers, multimeters, etc.)
  • Ability to manage software releases end to end
  • Experience with software CI/CD tools is a plus
  • Experience with sw/hw testing using test equipment (signal generator, oscilloscopes, logic analyzers, multimeters)
  • Experience in hardware and software integration (development, testing, and debugging)
  • Familiarity with Cybersecurity standards and guidelines is a plus
  • Experience and knowledge of IEC 62304, ISO13485 regulated Quality system, and FDA Guidance
  • Experience submitting software document for FDA submission
  • Full understanding of design control 21 CFR 820.30
  • Excellent documentation and oral and written communication skills
  • Strong background in troubleshooting system issues
  • Strong with medical device documentation; Software validation plan, test plan; Off the shelf or COTS or 3rd party validation plan, protocol
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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