Software Compliance Engineer
Core
Ensures digital applications and firmware for diabetes management products are developed, validated, and maintained in compliance with regulatory and corporate requirements.
Role type
Software Compliance Engineer (Quality Assurance)
Builds
Diabetes management software (cloud and mobile) and firmware
Domain
Healthcare / Medical Devices / Diabetes Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA QSR knowledge, ISO guidelines (13485, 14971), 21 CFR Part 11, Design Control requirements, Agile methodologies, defect management, test plan review, change impact analysis
Preferred skills
Medical device experience, Cybersecurity knowledge, Medical mobile applications experience, Cloud computing experience, ASQ Certifications
Technologies
Cloud platforms, Mobile application frameworks, FDA QSR tools, ISO compliance tools
Responsibilities
Review change plans for impact on software requirements and design; Review test plans and reports to ensure verification and regression; Monitor defect management process; Participate in Agile ceremonies; Maintain departmental operating procedures for compliance; Lead software quality tasks in development lifecycle phases; Estimate, plan, and schedule work products; Support internal and external audits
Seniority
Mid-level, hands-on IC