Software QE
Core
Lead quality engineering for Software as a Medical Device (SaMD), Embedded Software, and AI-enabled solutions, ensuring compliance with global medical device regulations throughout the software development lifecycle.
Role type
Senior Software Quality Engineer (Medical Devices)
Builds
SaMD, Embedded Software, Connected Medical Devices, and AI-enabled software solutions
Domain
Medical Devices / Healthcare Technology
Required skills
Software Quality Engineering, SaMD, Embedded Software, IEC 62304, ISO 13485, ISO 14971, FDA Design Controls, Agile, DevOps, CI/CD, Risk Management, Cybersecurity, Traceability
Preferred skills
AI/ML-enabled medical device software, Computer Software Assurance (CSA) (via careerplan.io/jobs/744000153403619-software-qe-at-intuitive)
Technologies
Jira, Azure DevOps
Responsibilities
Provide oversight of Design Controls, SDLC compliance, software verification and validation activities; Review and approve requirements, architecture, software design, risk management, cybersecurity, traceability, test protocols, test reports, and release documentation; Participate in software risk management, hazard analysis, and risk control verification activities; Support cybersecurity risk management in accordance with FDA guidance, AAMI TIR57/TIR97, and NIST frameworks; Provide quality oversight for Agile, DevOps, CI/CD, defect management, CAPA, root cause investigations, and software changes; Ensure end-to-end traceability from User Needs through Software Verification and Validation; Support regulatory submissions, audits, inspections, and post-market software quality activities; Drive continuous improvement initiatives and Computer Software Assurance (CSA) adoption.
Seniority
Senior, hands-on IC