About the job

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 global 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 and Design History Files (DHFs)/Technical Documentation to ensure requirements, outputs, verification, validation, and risk management activities are complete, traceable, and inspection-ready
Assess the impact of engineering changes on product performance, risk, regulatory submissions, and documentation, and ensure product risks are identified, evaluated, and controlled throughout the lifecycle
Support broader Quality Management System activities (CAPA, nonconformance investigations, supplier quality, audits) and drive a culture of quality by coaching cross-functional teams; collaborate with Regulatory Affairs on global submissions
Serve as Design Assurance SME during internal, Notified Body, and FDA audits/inspections, and identify opportunities to improve product development processes and Quality System effectiveness

Requirements

Bachelor's degree in Engineering, Life Sciences, or another technical discipline; advanced degree is a plus
5+ years of experience in Quality Engineering, Design Assurance, or Product Development Quality within the medical device industry, including new product development from concept through commercialization under Design Control requirements
Strong working knowledge of medical device Quality System regulations and international standards: ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, EU MDR, IEC 62366, and IEC 60601/62304 as applicable to the product
Solid experience with Design Controls, Design Reviews, Design Verification & Validation, Risk Management, Design Transfer, and sustaining engineering/lifecycle management of commercial medical devices
Demonstrated experience serving as Design Assurance or Quality Engineering SME during Notified Body audits, FDA inspections, and internal/external Quality System audits
Proven ability to lead and influence cross-functional teams without direct authority, with strong project management, organizational, analytical, and risk-based decision-making skills
Excellent written and verbal communication skills; proficient with Microsoft Office, eQMS, and PLM systems; self-motivated and collaborative in a fast-paced environment

Responsibilities