Instrument Design QA Lead
Core
Own the quality and compliance of medical device hardware and firmware across a dedicated product family, ensuring regulatory standards are met from design input to final transfer.
Role type
Senior Instrument Design QA Lead
Builds
Medical device product families (Skin, Heart, Tissue) for preventative care
Domain
Medical device hardware and firmware regulation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, risk management, change management, design transfer coordination, regulatory documentation, audit leadership, post-market surveillance, systems engineering, AI-driven workflows, eQMS, automated testing
Preferred skills
Notified Body interactions, audit experience, startup background, firmware development knowledge, standards committee participation
Technologies
eQMS, AI-assisted documentation, automated testing frameworks
Responsibilities
Lead risk management activities per ISO 14971, drive design controls across the product lifecycle, own change management, coordinate design transfer, support technical documentation for regulatory submissions, lead continuous improvement initiatives, act as QA subject matter expert for audits, participate in post-market surveillance
Seniority
Senior, hands-on IC