Sr SW Design Quality Assurance Engineer
Core
Senior Software Design Quality Assurance Engineer providing technical support and guidance to ensure conformance to software development processes and safety/quality regulations (IEC 62304, ISO 13485, ISO 14971) for cloud-based, data platform, and AI/ML-enabled systems.
Role type
Senior IC Software Design Quality Assurance Engineer
Builds
Cloud-based, data platform, and AI/ML-enabled systems for continuous glucose monitoring and consumer health technology
Domain
Medical Device / Consumer Health Technology / Cloud Infrastructure / AI/ML
Deliverable
production ML models
Required skills
Software design assurance, IEC 62304, FDA 21 CFR Part 820, ISO 13485, Software Hazard Analysis (SHA), design FMEA, requirements traceability, software configuration management, tool validation, risk management, change control assessment
Preferred skills
AI/ML experience, ASQ CSQE certification
Technologies
Cloud services, data pipelines, AI/ML components, distributed systems
Responsibilities
Provide hands-on technical guidance on global regulations for SaaS and data-driven products; lead application and continuous improvement of software development and validation practices; drive pre-market risk management deliverables including SHA and design FMEA; guide teams on design assurance activities like requirements traceability and configuration management; review and approve software design control deliverables for cloud and AI/ML components; support post-market activities related to anomalies and CAPA; author and maintain technical documentation including Design History Files and SOPs; assess change control activities for infrastructure and model changes.
Seniority
Senior, hands-on IC
