Job Description

Our client is an exciting, well-funded medical device innovator. The Software Quality Engineer will be the subject matter lead for all quality assurance and engineering activities throughout the software development lifecycle.

This is largely an onsite position (maybe 1 day/week from home) so we can only consider qualified candidates who live within a commutable distance to the corporate office (Palo Alto, Redwood City, Mountain View, Los Altos, Santa Clara, San Jose).

Responsibilities

• Lead the implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tool initiatives, through the integration of internal and external/medical device industry best practices
• Support software development through the creation of Design History Files (DHFs) including software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols, etc.
• Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes
• Ensure organizational compliance to the QMS system including ongoing training and education on software QMS and SDLC framework
• Provide CAPA, complaints, audit and overall QMS support

Qualifications/Experience

• BA/BS degree in Computer Science, Software Engineering, or related technical field
• 5+ years of software design assurance experience in the FDA QSR/ISO 13485 medical device industry, primarily working on software integrated into advanced electromechanical systems i.e. robotics
• Experience with the application of relevant standards including IEC 62304, AAMI TIR45, ISO 14971 and IEC 62366
• Demonstrated ability to implement and improve Software QMS processes using SDLC best practices, tools and agile/scrum/iterative methodology
• Highly collaborative and interpersonal relationship skills, strong verbal and written communication skills, with the ability to deliver quality outputs under minimal supervision

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