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Prismatik

Sr. QA Software Engineer (ISO 13485)

Prismatik Irvine, California, United States · $95K–$130K/yr

Software Development · 11-50 employees

4 d ago
qa Principal (10+ yrs) Full-time United States
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About the role

The role involves providing regulatory guidance and partnering with software development teams to ensure compliance with FDA and ISO 13485 standards throughout the SDLC. Responsibilities also include conducting software testing, managing risk assessments, and maintaining documentation such as traceability matrices and verification protocols.

What they look for

ISO 13485 FDA QSR IEC 62304 ISO 14971 IEC 60601 IEC 62366 Software Verification Software Validation Risk Management Cybersecurity Agile Scrum Kanban Cloud-based Software Web Development SDLC

Requirements

Candidates must hold a bachelor's degree in a technical field and possess at least eight years of experience in software engineering within the medical device industry. Proficiency in specific regulatory standards like IEC 62304, ISO 14971, and Agile methodologies is required.

Full description

Essential Functions:

  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Partners with software development teams in Software Development Lifecycle (SDLC) documentation including software development plans, software verification and validation, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
  • Participates in Quality Management System (QMS) activities in compliance with US FDA Quality System Regulations and ISO 13485.
  • Participates in software risk management activities including cybersecurity risk by collaborating and providing feedback to software development teams.
  • Remains current on existing and new regulations to support compliance of existing software.
  • Utilizes knowledge and expertise guide development team in seeking solutions and alternatives to meet regulations.
  • Conducts testing and assesses the effectiveness and accuracy of software against existing operating standards or performance guidelines.

Minimum Qualifications:

  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field; or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved.
  • Minimum eight (8) years of experience in software engineering in the FDA QSR/ISO 13485 within medical device industry.
  • Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 60601 (Medical Electric Equipment) and IEC 62366 Usability Engineering, required.
  • Experience with Agile software development methodologies like Scrum and Kanban, required.
  • Experience with other than embedded software development areas, such as web development, required.
  • Previous experience with cloud-based software, preferred.

Pay range: $95,000-130,000k/yr

Leveling and actual compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.

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