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About the Role
Level Zero is seeking a Senior Mechanical Design Engineer to lead the mechanical architecture of its wearable medical devices. This role involves hands-on design from concept through to volume manufacture, making key decisions on architecture, materials, and processes, while mentoring others and shaping product development.
Responsibilities
- Own and lead the mechanical architecture of Level Zero's wearable medical devices.
- Drive miniaturisation and integration, working with electronics, sensing and industrial design to package complex functionality into small, comfortable, body-worn form factors.
- Set mechanical design standards, CAD practices, drawing conventions and design review processes for the engineering team.
- Lead the design of injection moulded, overmoulded and precision components from concept through to production release.
- Define mechanical requirements, design specifications and architecture documentation, and ensure traceability within the design history file.
- Lead tolerance analysis and statistical tolerancing for critical assemblies to ensure robust performance and manufacturability at scale.
- Own mechanical risk management, leading DFMEA activities and contributing to PFMEA and overall product risk files.
- Define and oversee verification and validation strategies, including reliability, environmental, ingress, drop, wear and life-cycle testing.
- Lead root cause investigations into complex mechanical failures and drive effective, data-led design improvements.
- Champion 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 start.
- Select and manage external suppliers, moulders, tooling vendors and contract manufacturers, and lead tooling trials, pilot builds and design transfer.
- Balance performance, usability, reliability, manufacturability, regulatory requirements and cost across the product lifecycle.
Requirements
- Master's degree with 4+ years of industry experience in mechanical engineering, biomedical engineering or a related discipline.
- A track record of taking medical devices or consumer wearables from concept through to volume manufacture.
- Experience leading the mechanical design of highly miniaturised or densely integrated products.
- Expert CAD and drafting skills, including complex assemblies and surfacing, with a strong command of engineering drawings, GD&T and manufacturing tolerances.
- Extensive experience designing injection moulded plastic components for volume manufacture, including overmoulding, multi-shot or insert moulding.
- Experience leading tolerance stack analysis and applying statistical tolerancing to critical assemblies.
- Experience designing sealed, leak-tight or ingress-protected assemblies and developing associated test methods.
- Strong knowledge of assembly methods including snap fits, heat staking, ultrasonic and laser welding, adhesives and overmoulding.
- Experience leading DFMEA, contributing to PFMEA and applying structured risk management in line with ISO 14971.
- Experience working within an ISO 13485 or equivalent quality system, including design controls, change control, product release and PLM systems.
- Experience defining and executing V&V plans and mechanical test methods.
- Experience managing external suppliers, tooling vendors and contract manufacturers, including tooling trials and production transfer.
- Proven ability to lead structured root cause analysis on complex mechanical failures.
- Experience designing products with user needs at the centre of development.
- Experience mentoring engineers and leading technical design reviews.
- Strong communication skills and the ability to influence across multidisciplinary engineering teams and with senior stakeholders.
- 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 mechanisms
- Experience with IEC 60601, ISO 10993 biocompatibility or IEC 62366 usability engineering
- Experience designing precision mechanical mechanisms, such as applicators or insertion mechanisms
- Experience with sterilisation-compatible design and material selection
- Familiarity with Design of Experiments (DOE) and statistical data analysis
- Experience with FEA for structural, thermal or fatigue assessment
- Experience with rapid prototyping, machining and 3D printing
- Prior work in a start-up or small company environment
- Experience building or scaling an engineering team
Skills
- Mechanical Design
- CAD
- Drafting
- GD&T
- Manufacturing Tolerances
- Injection Moulding
- Overmoulding
- Multi-shot Moulding
- Insert Moulding
- Tolerance Stack Analysis
- Statistical Tolerancing
- Sealing
- Leak-tight Assemblies
- Ingress Protection
- Assembly Methods
- Snap Fits
- Heat Staking
- Ultrasonic Welding
- Laser Welding
- Adhesives
- DFMEA
- PFMEA
- Risk Management
- ISO 14971
- ISO 13485
- Design Controls
- Change Control
- Product Release
- PLM Systems
- Verification and Validation (V&V)
- Mechanical Testing
- Supplier Management
- Tooling
- Contract Manufacturing
- Root Cause Analysis
- Human-Centred Design
- Usability Engineering
- Communication
- Influencing
- Team Collaboration
- Problem Solving
- Startup Environment
- Leadership
- Mentoring
- Technical Design Reviews
- Fluid Handling Mechanisms
- Microfluidics
- IEC 60601
- ISO 10993
- IEC 62366
- Precision Mechanisms
- Sterilisation-compatible Design
- Design of Experiments (DOE)
- Statistical Data Analysis
- FEA
- Rapid Prototyping
- Machining
- 3D Printing
Work Type
- Full-time
Experience Level
- Senior
- 4+ years industry experience
Education Level
- Master's degree
Benefits
- Competitive salary
- Equity options
- Collaboration with founding team
- Access to industry experts and thought leaders
- Opportunities for leadership and career advancement
- Travel to New York and other potential sites for R&D purposes
About the Company
- 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.
- Backed by top-tier organisations like SOSV and Entrepreneur First.
- Pushing the boundaries of biochemistry and nanotechnology to revolutionize personalised health.
- Founded by two seasoned engineers with extensive experience in R&D, technical innovation, and commercial strategy.
- Mission: to revolutionise health management by delivering clinical-grade data directly to individuals, wherever they are.
- Assembling the best team in the world, dedicated to turning cutting-edge science into life-changing, real-world solutions.