Senior Quality Engineer - Product Development (m/f/d)

Hilo by Aktiia is a venture‑backed scale‑up developing the world’s only medically accurate, cuffless, continuous blood‑pressure monitor for everyday use. The company, headquartered in Neuchâtel, Switzerland and operating as a remote‑first organization, aims to eliminate deaths and damage caused by high blood pressure through its innovative technology, which holds CE Class IIa marking and received FDA clearance in 2026. As a Senior Quality Engineer you will act as the Design Assurance lead across the product development lifecycle. Your daily work involves partnering with engineering, product management, clinical, regulatory and project teams to embed design controls and risk‑management practices into new projects and design changes. You will guide design planning, reviews, verification, validation, transfer and change management, while ensuring that Design History Files, technical documentation and related records are complete, traceable and ready for inspection. In addition, you will oversee engineering change impacts, support CAPA, non‑conformance investigations, supplier quality activities and audit preparations, and coach cross‑functional groups on quality system requirements. The role requires a bachelor’s degree in engineering, life sciences or a comparable technical field, with an advanced degree considered advantageous. You must bring five to eight years of quality‑engineering experience in the medical‑device sector, specifically in design assurance or product‑development quality. A solid grasp of ISO 13485, FDA 21 CFR 820, ISO 14971, EU MDR and relevant IEC standards is essential, as is proven capability to lead cross‑functional teams, manage multiple projects, and communicate clearly in both written and spoken English. Proficiency with Microsoft Office, electronic QMS and PLM tools is also required. Preferred attributes include the ability to influence decisions without direct authority, strong analytical and problem‑solving skills, and a collaborative, hands‑on mindset that thrives in a fast‑paced environment. Hilo’s culture emphasizes moving the needle, and the remote‑first setup offers flexibility while being part of a mission‑driven team focused on life‑saving innovation.