
Senior Quality Engineer - Product Development (m/f/d) at Hilo By Aktiia
Cuffless AI-driven blood pressure monitoring transforming global health.
Quality/design assurance role for medical device product development; leads design controls, risk management, verification/validation, design transfer, design changes, DHF/technical documentation, and inspection readiness across new products and sustaining engineering; partners with engineering, product, clinical, regulatory, and project management; supports global regulatory submissions and serves as SME in Notified Body audits and FDA inspections; requires bachelor's in engineering/life sciences/technical field and 5–8 years in medical device quality engineering/design assurance/product development quality; strong knowledge of ISO 13485, 21 CFR Part 820/QMSR, ISO 14971, EU MDR, IEC 62366, and as applicable IEC 60601/62304; experience with eQMS and PLM systems
Remote United Kingdom only

















