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

Senior Quality Engineer, Product Development at Hilo by Aktiia is a senior‑level position within a venture‑backed scale‑up that develops a cuffless, continuous blood‑pressure monitor. The company's vision is a world where high blood pressure never leads to loss of life, and its technology, built on more than a decade of research at the Swiss Center for Electronics and Microtechnology, is already CE‑marked (Class IIa) and FDA‑cleared. Hilo by Aktiia operates remotely‑first from its headquarters in Neuchâtel, Switzerland, and the role sits at the intersection of engineering, product management, clinical, regulatory and project‑management functions. On a daily basis the Senior Quality Engineer partners with cross‑functional teams to support new product development and design changes for commercial devices. Core duties include planning and executing design‑control and risk‑management activities, leading design‑assurance tasks such as design reviews, verification, validation, design transfer and change management, and reviewing documentation to guarantee that requirements, outputs, verification, validation and risk‑mitigation evidence are complete, consistent and traceable. The engineer also ensures that Design History Files, technical documentation and related records are inspection‑ready, oversees engineering change impact assessments, and contributes to broader quality‑system work such as CAPA, non‑conformance investigations, supplier quality, audits and continuous‑improvement initiatives. The role demands a bachelor's degree in engineering, life sciences or a comparable technical discipline, with five to eight years of experience in quality engineering, design assurance or product‑development quality within the medical‑device sector. Candidates must possess strong working knowledge of the relevant quality‑system regulations and standards, ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MDR, IEC 62366, IEC 60601 and IEC 62304, as well as proven experience with design controls, risk management, verification and validation, and lifecycle management of commercial devices. The ability to lead cross‑functional teams without direct authority, excellent written and verbal communication, solid project‑management and prioritisation skills, and proficiency with Microsoft Office, electronic QMS and PLM tools are also required. Additional strengths that would be valuable include an advanced degree (e.g., MSc or PhD), prior involvement in design‑change and sustaining‑engineering projects, and experience acting as the design‑assurance subject‑matter expert during Notified‑Body audits, FDA inspections or internal quality audits. The position offers a fast‑paced, collaborative environment where a hands‑on, self‑motivated attitude is prized, and it benefits from the company's remote‑first culture and its mission‑driven focus on improving global health outcomes. What the role asks for: - Bachelor's degree in Engineering, Life Sciences or related field - 5–8 years Quality Engineering / Design Assurance experience in medical devices - Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971 - Experience with design controls, risk management, verification & validation - Proven ability to lead cross‑functional teams without direct authority - Excellent written and verbal communication skills - Proficient with Microsoft Office, eQMS and PLM systems - Nice‑to‑have: advanced degree (MSc or PhD)