Jobs

Neko Health is seeking an Instrument Design QA Lead to own the quality and compliance of their medical device hardware and firmware for a dedicated product family. This critical role ensures all products meet regulatory standards from design to transfer, holding authority to approve or reject quality deliverables. The ideal candidate will have 5+ years of medical device QA experience with deep expertise in design controls and risk management, including EU MDR, ISO 13485, and FDA regulations. You will lead risk management, drive design controls, manage changes, and support regulatory submissions, playing a key part in delivering safe and effective devices for Neko's preventative care mission.