Staff SW QA Engineer
Core
Technical leader for software quality assurance, risk management, and regulatory compliance in medical device software.
Role type
Staff Software Quality Engineer (Medical Device)
Builds
Scalable quality systems, risk management practices, and software compliance strategies for continuous glucose monitoring (CGM) devices.
Domain
Medical Device / Biosensing Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, EU MDR, software risk management, DFMEA, PFMEA, SHA, hazard analysis, software development lifecycle (SDLC), Agile, Waterfall, DevOps, CI/CD, test automation, software architecture, distributed systems, cybersecurity, data platforms, regulatory inspections, cross-functional leadership, mentoring.
Preferred skills
Digital transformation initiatives (ALM, SCM, PLM), emerging regulations and standards assessment, right-sized QMS applications.
Technologies
ALM, SCM, PLM, electronic systems supporting SDLC
Responsibilities
Lead effective application and continuous improvement of software development and V&V processes; lead complex software quality initiatives spanning multiple products; lead risk assessments for software anomalies, cybersecurity vulnerabilities, and post-market issues; provide technical oversight for software risk management activities; review and approve critical quality deliverables; drive organizational improvements related to software quality systems and automation; evaluate emerging regulations and assess impact; collaborate with senior leadership to define quality strategies; mentor software quality engineers and cross-functional teams.
Seniority
Staff, technical leadership and mentorship
