Validation & Verification Lead - SaMD

Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.   In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Neko's vision is to shift healthcare from reactive treatment toward preventative health and early detection. This requires completely reimagining the patient's experience and incorporating the latest advances in sensors and AI. Neko Health has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is convenient and affordable for the public. The company is based in Stockholm, offering the Neko Body Scan experience at locations in Stockholm, London and Manchester, with over 500 employees. The role We are looking for a Verification & Validation Lead to take ownership of the V&V strategy and execution for our Software as a Medical Device (SaMD) and complex interconnected systems. You will define verification and validation strategies, ensure traceability between requirements and test activities, and drive V&V execution across the product lifecycle. You will work closely with software, firmware, quality, and regulatory teams to ensure our systems meet safety, performance, and regulatory requirements. What you’ll do - Lead Verification & Validation activities for SaMD and complex interconnected systems across product development projects - Define and drive the V&V strategy, including traceability, test methodology, and generation of audit-ready verification and validation documentation - Ensure V&V processes are properly implemented in accordance with SOPs, and contribute to improving V&V processes, work instructions, and infrastructure - Collaborate with cross-functional teams to ensure requirements are clear, testable, and traceable - Represent Verification & Validation in product changes and regulatory submissions, including interactions with regulatory authorities such as the FDA Who you are - Bachelor’s or Master’s degree in Engineering or a related technical field - Proven experience leading Verification & Validation in regulated product development environments, ideally within medical devices or SaMD - Strong understanding of software lifecycle processes, system integration, and system-level verification - Experience supporting regulatory submissions and producing audit-ready documentation - Familiarity with regulatory frameworks such as FDA, MDR, and ISO 14971 - Strong collaboration and communication skills, with the ability to work across engineering, quality, and regulatory teams About titles at Neko We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process. Hiring Process Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team. Equal Opportunity & Inclusion Statement Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.