05 oct
|
Hilo By Aktiia
|
España
05 oct
Hilo By Aktiia
España
About Hilo By Aktiia
High blood pressure is the world's most common disease, causing 18M deaths each year. At Hilo by Aktiia, we're building a world where no lives are lost to its effects — with technology that helps people take control of their health.
We're a venture-backed scale-up with $96M raised from investors in Europe and the US. Rooted in 18 years of research at the Swiss Center for Electronics and Microtechnology (CSEM), our device is the world's only medically accurate, cuffless, continuous blood pressure monitor for daily use — clinically validated and CE Marked as a Class IIa medical device, now available in 12 countries. In July, we launched in the US.
We're a remote-first company headquartered in Neuchâtel, Switzerland, united by our passion for impact and innovation.
Role Overview
This role provides Quality Engineering leadership across Design Controls, Risk Management, and Quality System requirements throughout the product development lifecycle, partnering with Engineering, Product Management, Clinical, Regulatory Affairs,
and Project Management to bring new products and design changes to commercial products in compliance with general medical device regulations. As a key Design Assurance resource, the Senior Quality Engineer works independently in a fast-paced environment to ensure design documentation is complete, compliant, and inspection-ready.
ResponsibilitIies
• Partner with cross-functional teams (Engineering, Product Management, Clinical, Regulatory Affairs, Project Management) to support new product development and design changes to commercial products
• Provide Quality leadership and ensure compliance with Design Controls, Risk Management, and Quality System requirements throughout new product development and sustaining engineering projects
• Lead and facilitate Design Assurance activities: design planning, design reviews, verification & validation planning, design transfer, and design change management
• Review design documentation a
📌 Senior Quality Engineer (España)
🏢 Hilo By Aktiia
📍 España