Sr Staff SW QA Engineer
Core
Provide technical leadership for software quality assurance, risk management, and regulatory compliance for clinical applications and hospital space in medical devices.
Role type
Sr Staff Software QA Engineer (Medical Device)
Builds
Clinical Applications and Hospital space software ensuring safety, effectiveness, and regulatory compliance
Domain
Medical Device / Consumer Health Technology
Required skills
FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, Software Development Lifecycle, Agile, Waterfall, DevOps, CI/CD, Test Automation, Software Risk Management, DFMEA, PFMEA, SHA, Hazard Analysis, ALM, SCM, PLM, Cloud technologies, Distributed systems, Cybersecurity
Preferred skills
Mentoring engineers, Influencing senior stakeholders, Managing ambiguity, Executive-level communication
Technologies
ALM, SCM, PLM, Cloud platforms, Distributed systems (via careerplan.io/jobs/JR120209-sr-staff-sw-qa-engineer-at-dexcom)
Responsibilities
Develop enterprise-level software quality strategies and policies; Lead complex software quality initiatives spanning multiple products; Lead risk assessments for software anomalies and cybersecurity vulnerabilities; Provide technical oversight for software risk management activities; Review and approve critical quality deliverables including V&V protocols and design history files; Drive organizational improvements in automation and compliance processes; Mentor software quality engineers and cross-functional teams.
Seniority
Sr Staff, hands-on IC with strategic influence