A client in the Medical Device industry is seeking a Sr. Software Quality Assurance Engineer to support the full product development life cycle for their commercial implantable pain management device group. The role will entail development, testing, and validation of software + firmware products within a highly regulated medical device environment. This resource will be responsible for maintaining quality standards of their software systems, validating firmware requirements, and adhering to security compliance requirements throughout the product life cycle from requirements gathering through retirement phases. The ideal candidate will be comfortable creating and executing Design Validation Plans, Protocols, and Reports for system level testing and be detailed regarding documentation of user requirements, hazard analysis, risk assessment, etc. This resource will be joining a team of Product Quality Engineers helping support validation activities encompassing User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis. This role is hybrid, onsite 3 days a week in Valencia, CA.

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Required Skills & Experience

BS Degree in Computer Science or Software/Electrical Engineering
5+ years of Software Quality experience OR applicable higher education (MS/PhD)
3+ years of Software Testing within a Commercial Product team
Manual Testing + Documentation experience within a regulated environment
Understanding of the SDLC and applicable technologies (C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView)
Strong organizational and written/verbal communication skills within team environment

Nice to Have Skills & Experience

Medical Device, Highly Regulated Industry, or Neuromodulation/Implantable device experience.
Experience with CAPA, Compliant Handling and External Audit, Risk Management (ISO14971), Pre/Post Market Cybersecurity.
Experience with Mobile Application development or Bluetooth technology
Understanding of HIPAA and GDPR Compliance
ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) certs.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.