H3ustrongAbout Hilo by Aktiia /strong /u /h3pHigh blood pressure is the world’s most common disease, causing 18M deaths each year. At strongHilo by Aktiia /strong, our vision is a world where no lives are lost or damaged from the effects of high blood pressure. Our mission is to make this a reality by developing tech to help people control their blood pressure. /ppWe are a venture-backed scale-up company, having raised over $96M from investors in Europe and the United States. Our technology - rooted in 18 years of research at the Swiss Center for Electronics and Microtechnology (CSEM) - is the world’s only medically accurate, continuous blood pressure monitor that is cuffless in daily life in the consumer space. Validated through extensive clinical trials and CE Marked as a Class IIa medical device, our solution is now available in 12 countries. We are a hybrid/remote-first company, with Headquarters in Neuchâtel, Switzerland, united by our passion for impact and innovation. /p h3ustrongRole Overview /strong /u /h3pWe are looking for a highly motivated strongSenior Quality Engineer /strong to strengthen our quality and manufacturing excellence at Hilo by Aktiia. In this role, you will play a critical part in ensuring the reliability, compliance, and continuous improvement of our medical device products across their full lifecycle. /ppThis is a senior, hands-on role where you will take ownership of quality processes across manufacturing, supplier management, and product lifecycle activities. You will work cross-functionally with development, operations, and manufacturing teams to ensure that all products meet the highest standards of quality and regulatory compliance. /ppYou will act as a key driver of quality culture within the organization leading investigations, improving processes, and ensuring that both internal teams and external partners operate in alignment with medical device regulations and best practices. /ppThis role requires a proactive mindset, strong technical judgment, and the ability to operate independently while adapting to evolving priorities in a fast-paced startup environment. /p h3uCore Responsibilities /u /h3 pstrongManufacturing Quality Process Excellence /strong /pulliPartner with manufacturing teams and contract manufacturers to lead and support quality engineering activities /liliDrive and support process validations (IQ, OQ, PQ) and test method validations /liliEnsure robust manufacturing process controls and continuous improvement initiatives /liliResolve non-conformances and ensure effective root cause analysis and corrective actions /li /ul pstrongCAPA Quality Systems Leadership /strong /pulliLead cross-functional efforts to investigate and resolve quality issues /liliOwn and drive CAPA processes, ensuring timely and effective implementation /liliEnsure ongoing compliance with QMS requirements and regulatory standards /liliMonitor quality system performance and identify areas for improvement /li /ul pstrongProduct Quality Release Management /strong /pulliReview and approve LHRs, DHF deliverables, product releases, and engineering change orders /liliEnsure all product documentation meets internal procedures and regulatory expectations /liliSupport labeling reviews to ensure compliance with applicable standards and usability requirements /li /ul pstrongSupplier Quality Management /strong /pulliLead supplier management activities, including audits, qualifications, and performance assessments for contract manufacturers /liliCollaborate closely with contract manufacturers to ensure consistent quality standards /liliDrive improvements across the contract manufacturing supplier network to enhance product quality and reliability /li /ul pstrongCross-Functional Collaboration /strong /pulliWork closely with development, operations, manufacturing, and quality teams /liliAct as a quality subject matter expert across projects and initiatives /liliSupport internal and external audits, ensuring readiness and successful outcomes /liliCoach internal teams and external partners on GMP and QMS requirements /li /ul pstrongContinuous Improvement Quality Culture /strong /pulliLead initiatives to improve product quality and operational efficiency /liliPromote a strong culture of quality, accountability, and continuous improvement /liliIdentify opportunities to streamline processes and increase scalability /li /ulpstrongRequirements /strong /ppstrongExperience /strong /pulli5–8+ years of experience in quality engineering or manufacturing within the medical device industry /liliHands-on experience working with finished medical devices /liliStrong experience with contract manufacturing environments /liliBachelor’s degree in a technical or scientific field /li /ul pstrongQuality Regulatory Expertise /strong /pulliSolid knowledge of medical device regulations and standards (MDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820) /liliExperience with risk management processes (e.g., process and design FMEA) /liliFamiliarity with QMS systems and audit processes /li /ul pstrongLeadership Mindset /strong /pulliStrong ownership and ability to work independently with minimal supervision /liliProven ability to lead cross-functional initiatives and drive results /liliExcellent problem-solving skills with a structured and analytical approach /liliAbility to manage multiple priorities in a dynamic environment /li /ul pstrongTools Ways of Working /strong /pulliProficiency with MS Teams, Word, Excel, and PowerPoint /liliExperience with eQMS systems and modern digital tools (including AI-supported workflows) /liliStrong project and time management skills /li /ul pustrongWhat Success Looks Like /strong /u /pulliManufacturing and quality processes operate reliably, efficiently, and in full compliance /liliQuality issues are resolved quickly and systematically, with strong root cause understanding /liliSupplier quality is consistently high and continuously improving /liliCross-functional teams are aligned on quality standards and best practices /liliQuality becomes a strong enabler of product excellence and scalability /li /ul pstrongWhat Makes You a Great Fit /strongbrAt Hilo by Aktiia, our values guide how we work and grow: /p pstrongMove the Needle /strong /pulliYou focus on what drives real impact for product quality and patient safety /liliYou prioritise effectively and push for meaningful improvements /liliYou maintain a high bar for quality and execution /li /ul pstrongMove Fast, Learn, Refine /strong /pulliYou act with urgency while maintaining rigor and compliance /liliYou continuously improve processes and outcomes /liliYou adapt quickly to new challenges and evolving priorities /li /ul pstrongTeam First /strong /pulliYou collaborate effectively across teams and functions /liliYou communicate clearly and provide constructive feedback /liliYou contribute to a culture of trust, accountability, and excellence /li /ulpstrongBenefits /strong /ph3uWhy Join Us? /u /h3ulliHilo by Aktiia is becoming one of the most important med-tech companies, and you can be part of this exciting story /liliWork on a mission that matters: transforming cardiovascular health at global scale /liliBe part of a high-impact, fast-growing, and venture-backed scale-up company /liliCollaborate with a diverse, passionate, and talented team /liliCompetitive compensation and equity program, and other benefits (depending on location) /li /ul