Lead Product Development Engineer - Medical Devices

About Droplet Scientific Modern hospitals continuously track heart rate, blood pressure and oxygen levels. Yet biochemical measurements still depend on infrequent and intermittent blood samples. Important changes between tests can go unseen, making it harder to recognise trends, assess treatment response and act at the right time. We are working to change that. Droplet Scientific is a startup developing a new platform for continuous biochemical monitoring. Using proprietary droplet microfluidics, our technology is designed to measure clinically important biomarkers and therapeutic drug concentrations automatically and in near real time, giving clinicians a clearer and more actionable picture of each patient's condition. We are building a multidisciplinary team across engineering, chemistry, product development and manufacturing to turn our established research-use technology into robust, scalable products for healthcare and the life sciences. Join us to help create this new monitoring technology with the potential to improve clinical decision-making and patient care. About the role We are looking for a hands-on Lead Product Development Engineer to take responsibility for the physical product as it moves from an established research-use system to a robust, scalable and production-ready medical device. You will lead the mechanical architecture and detailed design, own the CAD and work directly with colleagues, suppliers and manufacturing partners to take the product into production. What you will do

• Translate user, clinical, regulatory and manufacturing needs into clear design requirements, acceptance criteria and practical engineering solutions.
• Own the 3D CAD and detailed mechanical design, including parts, assemblies, interfaces, materials, tolerances, production drawings and specifications.
• Build and test prototypes, plan mechanical verification activities, use analysis, reliability testing and structured root-cause investigation to improve performance.
• Own the product design sections of the technical documentation and support verification, risk management and regulatory activities within the company's ISO 13485 quality management system.
• Lead mechanical risk analysis and implement design mitigations in collaboration with quality, regulatory and other technical disciplines.
• Apply design for manufacture and assembly throughout development and work directly with component suppliers, tooling specialists and manufacturing partners,
• Lead design reviews and manage technical trade-offs between performance, usability, manufacturability, cost, reliability and development timescales.
• Maintain controlled design outputs and technical rationale through design freeze, verification, design transfer and subsequent design changes.
• Work closely with colleagues across electronics, software, microfluidics, chemistry, quality and manufacturing to ensure the complete system works safely, reliably and consistently. What you will bring
• 5+ years of proven product-development experience, including substantial responsibility for taking at least one physical product from prototype into manufacture a regulated environment.
• Strong hands-on 3D CAD capability, with experience owning complex assemblies and production drawings.
• Practical knowledge of DFM and DFA, injection moulding, tooling and production constraints, gained through direct work with suppliers and manufacturing partners.
• Strong systems thinking, with the ability to understand and manage interfaces between mechanical, fluidic, electronic and other product elements.
• Evidence-led engineering judgement, including the ability to investigate problems, evaluate trade-offs and make decisions where information is incomplete.
• The ability to lead technical work independently, communicate design decisions clearly and collaborate effectively across different disciplines.
• A structured and disciplined approach to technical documentation, configuration control and design changes. Particularly valuable experience
• Medical devices, IVDs, scientific instruments or other regulated products.
• Single-use fluid paths, cartridges, microfluidics or other small-volume liquid-handling products.
• Designing for sterilisation, biocompatibility or clean manufacturing environments.
• Applying ISO 13485 design controls, ISO 14971 risk management or IEC 62366-1 usability engineering. Why join Droplet
• Meaningful ownership: You will have the opportunity to shape a core capability within the company, rather than inherit a narrowly defined role or task list.
• A real product challenge: Your work will sit at the intersection of science, engineering, regulated product development and manufacturing, with a clear path towards clinical use.
• Multidisciplinary collaboration: You will work closely with the founders, clinicians and colleagues across microfluidics, chemistry, engineering, quality, regulatory and manufacturing.
• Visible impact: In a small, fast-moving team, your work can quickly become part of a real product, with the potential to improve how patients are monitored and cared for.
• Share Option scheme