Senior Mechanical Design Engineer

About Level Zero Level Zero is pioneering next-generation biosensor technology for precise, real-time monitoring of critical endocrine biomarkers. Recognised as one of the top 20 startups across all categories worldwide at TechCrunch Disrupt 2024 - and backed by top-tier organisations like SOSV and Entrepreneur First - we're pushing the boundaries of biochemistry and nanotechnology to revolutionize personalised health. Founded by two seasoned engineers, we bring extensive experience in R&D, technical innovation, and commercial strategy to transform the way people monitor their health. Our mission is bold: to revolutionise health management by delivering clinical-grade data directly to individuals, wherever they are. We're seeking driven innovators to join us in pushing the boundaries of biosensing and health tech, making personalised health monitoring a reality for everyone. To achieve this ambitious vision, we're assembling the best team in the world - dedicated to turning cutting-edge science into life-changing, real-world solutions. We're looking for a Senior Mechanical Design Engineer to lead the mechanical architecture of Level Zero's wearable medical devices, from early concept through to design transfer and volume manufacture. Working directly with the founding team and a multidisciplinary engineering group, you'll set the mechanical direction for highly miniaturised, body-worn products, making the key decisions on architecture, materials, manufacturing processes and risk. This is a hands-on senior role for someone who wants to own the mechanical design of a medical wearable end to end, while mentoring others and shaping how we develop products as we grow. What You'll Do Own and lead the mechanical architecture of Level Zero's wearable medical devicesDrive miniaturisation and integration, working with electronics, sensing and industrial design to package complex functionality into small, comfortable, body-worn form factorsSet mechanical design standards, CAD practices, drawing conventions and design review processes for the engineering teamLead the design of injection moulded, overmoulded and precision components from concept through to production releaseDefine mechanical requirements, design specifications and architecture documentation, and ensure traceability within the design history fileLead tolerance analysis and statistical tolerancing for critical assemblies to ensure robust performance and manufacturability at scaleOwn mechanical risk management, leading DFMEA activities and contributing to PFMEA and overall product risk filesDefine and oversee verification and validation strategies, including reliability, environmental, ingress, drop, wear and life-cycle testingLead root cause investigations into complex mechanical failures and drive effective, data-led design improvementsChampion human-centred design, leading human factors studies, usability evaluations and user research, and ensuring wearability, comfort and ease of use are designed in from the startSelect and manage external suppliers, moulders, tooling vendors and contract manufacturers, and lead tooling trials, pilot builds and design transferBalance performance, usability, reliability, manufacturability, regulatory requirements and cost across the product lifecycle The ideal candidate must have Master's degree with 4+ years of industry experience in mechanical engineering, biomedical engineering or a related disciplineA track record of taking medical devices or consumer wearables from concept through to volume manufactureExperience leading the mechanical design of highly miniaturised or densely integrated productsExpert CAD and drafting skills, including complex assemblies and surfacing, with a strong command of engineering drawings, GD&T and manufacturing tolerancesExtensive experience designing injection moulded plastic components for volume manufacture, including overmoulding, multi-shot or insert mouldingExperience leading tolerance stack analysis and applying statistical tolerancing to critical assembliesExperience designing sealed, leak-tight or ingress-protected assemblies and developing associated test methodsStrong knowledge of assembly methods including snap fits, heat staking, ultrasonic and laser welding, adhesives and overmouldingExperience leading DFMEA, contributing to PFMEA and applying structured risk management in line with ISO 14971Experience working within an ISO 13485 or equivalent quality system, including design controls, change control, product release and PLM systemsExperience defining and executing V&V plans and mechanical test methodsExperience managing external suppliers, tooling vendors and contract manufacturers, including tooling trials and production transferProven ability to lead structured root cause analysis on complex mechanical failuresExperience designing products with user needs at the centre of developmentExperience mentoring engineers and leading technical design reviewsStrong communication skills and the ability to influence across multidisciplinary engineering teams and with senior stakeholders Nice to have: Experience designing skin-adhered or continuously worn medical devices (e.g. CGMs, patch pumps, cardiac monitors)Experience designing pumps, valves, diaphragms, microfluidics or other fluid-handling mechanismsExperience with IEC 60601, ISO 10993 biocompatibility or IEC 62366 usability engineeringExperience designing precision mechanical mechanisms, such as applicators or insertion mechanismsExperience with sterilisation-compatible design and material selectionFamiliarity with Design of Experiments (DOE) and statistical data analysisExperience with FEA for structural, thermal or fatigue assessmentExperience with rapid prototyping, machining and 3D printingPrior work in a start-up or small company environmentExperience building or scaling an engineering team Who You Are We value culture as much as we value technical expertise, creating an environment that's equal parts collaboration, curiosity, and fun. We're a fast-paced, mission-driven young team on a quest to make a lasting impact, fueled by uncompromising integrity, unwavering support for one another, and the thrill of exploring uncharted territories. Our passion for excellence drives everything we do, and we welcome individuals who share our commitment to shaping the future. If our vision excites you, here are the qualities we look for: You live and breathe integrity, tackling challenges with honesty and transparencyYou're a self-starter who loves diving into the unknown, collaborating on complex problems, and taking full ownership of resultsYou excel at open, clear communication and see every piece of feedback as a springboard for growth—especially in a science and data-focused environmentYou're motivated by creating real impact, particularly when it comes to advancing human healthYou strike a balance between independence and collaboration, knowing when to seek support or invite others to join inYou're confident in defending your ideas, while also valuing respectful, constructive debate as a path to better solutionsYou thrive in the dynamic atmosphere of a startup, constantly evolving your skill set and fearlessly applying what you learn What We Offer A full-time role with a competitive salary and equity options, reflecting our value in your expertise and potentialAn environment where you'll collaborate directly with the founding team at a leading biosensor startup, gaining access to industry experts and thought leadersThe chance to grow with us, including ample opportunities for leadership, career advancement, and explorationTravel to New York and other potential sites for R&D purposesThe excitement of working on cutting-edge technology, shaping strategic decisions, and driving innovation at an early-stage venture alongside a superstar team Be Part of Our Journey If you're ready to be at the forefront of biosensing innovation and thrive in fast-paced, learning-rich environments, we'd love to hear from you. If your skills and experience do not align perfectly with this role, yet you believe you have something unique to offer, we're keen to listen. Reach out to us with a short statement on how you can contribute and let's discuss where you might fit into our team.