Sr. Software Quality Engineer

A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a defined two-year term to backfill a team member assigned to internal projects. The ideal resource will be well versed in Quality SW principles within the medical device industry and have deep expertise in risk assessment, testing, and design validation. This resource should be detail oriented with strong documentation and able to identify risks and process improvements on their own to share with cross functional teams including R+D, Marketing, Regulatory, etc. This resource's time will be split up into 50% design validation activities, 30% SDLC work, and 20% risk management through testing. This role will be hybrid, onsite 3 days per week in Valencia, CA.

• Bachelor's degree in Computer Science, Engineering, or related field

• 5+ years of experience in Software Quality related roles

o Well versed in testing processes/methodologies and risk assessment

• Experience in Medical Device industry or other highly regulated spaces

o Well versed with manual system-level testing in regulated environments

• Deep understanding of the SDLC per IEC 62304 and IEC 82304

o Knowledge of programming languages like C#, C++, Swift, Node.js, Java/Javascript, Python, etc.

• Risk Management experience working with ISO 14971 * Advanced Degree in a related field

• Experience with Neuromodulation products

• Exposure to CAPA/Complaint handling or external audits

• Quality Engineering Certifications (CQE or CSQE)