Senior Engineer, Software Test in Fremont

The Senior Engineer, Software Test will be responsible for conducting testing of software for a robotic surgical system. The Senior Software Test Engineer is responsible for reviewing software requirements and ensuring requirements are fully tested; designing, implementing, and documenting new tests as well as updating existing tests; executing tests and documenting test results; assisting in development of test automation and automation frameworks; assisting in training junior members of the team. The successful candidate will also be knowledgeable of industry standards and regulations for medical device development. This position is based in the Fremont, CA office., * Work cross-functionally to review requirements to ensure they are complete, accurate, nonconflicting and testable, as well as develop tests ensuring coverage of requirements is complete.

• Increase depth of testing - find those difficult to find bugs.
• Document test protocols following internal SOPs and industry guidance and standards.
• Update existing tests for correctness.
• Assist team lead with planning and estimating testing activities for large projects.
• Assist in maintaining the traceability matrix.
• Execute tests and document results for regulatory submissions.
• Assist in developing automated tests and frameworks.
• Mentor junior members of team on test development, and SOPs and WIs.
• Help devise and enforce procedures for following internal SOPs and guidance documents.
• Help devise improved procedures and processes to increase team’s efficiency.

• BS in Computer Science or related field.
• 7 years’ experience testing software with at least 3 years testing medical devices.
• Good knowledge of IEC 62304, ISO 14971, ISO 13485, and General Principles of Software.
• Validation - Final Guidance for Industry and FDA Staff.
• Ability to program in C++ or at least one scripting .
• Experience using commercial test automation tools.
• Excellent communication and documentation skills.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

:

• MS in Computer Science or related field.
• 10 years’ experience testing software with at least 5 years testing medical devices.
• Experience building test automation frameworks from scratch.
• Experience leading small teams of testers.
• Experience with Linux or QNX.

COMPETENCIES

• Decisive
• Demonstrate leadership
• Dependable
• Communicate effectively
• Collaborative
• Produce high quality work

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.

• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.

• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.

• Occasionally work around moving mechanical parts.

• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.

• Must be able to travel as business necessitates (up to 5%).