Mechanical Design Engineer

About Level Zero

Level Zero is at the forefront of developing next-generation biosensor technology for accurate, real-time tracking of key endocrine biomarkers. Recognised globally as one of the top 20 startups at TechCrunch Disrupt 2024 and supported by premier investors like Redalpine, SOSV, and Entrepreneur First, we are breaking new ground in biochemistry and nanotechnology to transform personalised health management.

Established by two experienced engineers, our company combines deep expertise in research and development, technological innovation, and commercial strategy with the aim to deliver clinical-grade health data directly to individuals worldwide.

We invite passionate innovators to join our mission to make personalised health monitoring accessible to all. To accomplish this ambitious goal, we are assembling a world-class team committed to turning cutting-edge science into impactful, real-world applications.

Key Responsibilities

• Lead the mechanical design and development of plastic components for wearable devices and integrated pump systems.
• Create durable injection-moulded plastic parts, managing projects from initial concept through to release for manufacturing.
• Develop precise 3D CAD models, assemblies, and technical drawings that meet manufacturing standards.
• Carry out tolerance analyses and stack-ups to guarantee product reliability and manufacturability, alongside generating detailed design specifications and mechanical architecture documents.
• Design, implement, and refine verification testing methods to assess product functionality and durability. Organise and interpret engineering tests to drive design improvements based on data.
• Investigate mechanical issues thoroughly, determine root causes of failures, and introduce effective enhancements.
• Incorporate human-centered design principles through user factor studies, usability testing, and user research sessions to translate insights into design improvements.
• Collaborate extensively with external suppliers and manufacturing partners to prepare production-ready components.
• Specify, qualify, and integrate purchased components into the product in partnership with suppliers.
• Work closely with cross-functional teams including electronics, systems engineering, quality assurance, manufacturing, and industrial design.
• Balance competing factors such as technical performance, user experience, reliability, manufacturability, and cost throughout the design lifecycle.
• Contribute to early-stage research and development efforts by partnering with engineering leadership to define and evolve future product versions.

Candidate Profile

• Master’s degree in biomedical engineering, mechanical engineering, or a related field with 2 to 4 years of relevant industry experience.
• Proven track record in designing products centered around user needs.
• Experience developing pump systems, valves, diaphragms, or analogous fluid handling components, including leak-tight assemblies and leak testing methods.
• Advanced skills in CAD and drafting, including complex assemblies and appropriate surfacing, along with strong knowledge of engineering drawings, GD&T, and manufacturing tolerances.
• Proficiency in conducting tolerance stack analyses and applying statistical tolerancing.
• Expertise in producing engineering documents such as design specifications and product requirements, with familiarity in DFM, DFA, and DFMA principles, and experience engaging with suppliers, manufacturers, and tooling vendors.
• Experience creating and optimizing mechanical test methods and verification strategies.
• Experience with DFMEA, PFMEA, and comprehensive engineering risk management processes.
• Demonstrated capability designing injection moulded plastic parts for mass production, participating in tooling trials, and resolving manufacturing challenges.
• Strong troubleshooting skills for mechanical failures using structured root cause analysis.
• Familiarity with assembly techniques such as snap fits, heat staking, ultrasonic welding, adhesives, and overmoulding.
• Experience with engineering change control processes, product release protocols, and PLM systems.
• Excellent communication skills and a collaborative approach to multidisciplinary team environments.
• Ability to independently manage significant subsystems, working under appropriate guidance.

Preferred Qualifications

• Experience developing devices for dermal interstitial fluid extraction.
• Background in designing wearable medical devices.
• Knowledge of quality standards such as ISO 13485 and ISO 14971.
• Familiarity with verification and validation (V&V) testing protocols.
• Experience with reliability, environmental, fatigue, or lifecycle testing.
• Skill in designing precision mechanical mechanisms and miniature or highly integrated assemblies.
• Hands-on experience with rapid prototyping, machining, and 3D printing.
• Understanding of Design of Experiments (DOE) and statistical data evaluation.
• Involvement in pilot builds, manufacturing scale-up, and production transfer processes.
• Basic expertise in finite element analysis (FEA) for structural or thermal evaluation.
• Previous work experience in start-ups or small companies.
• Prior exposure to medical device development.

Personal Attributes

• Strong integrity and transparent approach when addressing challenges.
• Self-motivated with a passion for exploring new problems, collaborating effectively, and taking full ownership of outcomes.
• Excellent communication skills that foster openness, receptiveness to feedback, and continuous improvement in a scientific and data-driven setting.
• Motivation driven by making tangible impacts in advancing human health.
• Ability to balance autonomy with teamwork, knowing when to seek assistance or involve others.
• Confidence in advocating for ideas while appreciating constructive debate as a means to produce superior solutions.
• Comfortable thriving in a dynamic startup environment, embracing continuous learning and applying new skills.

What We Offer

• A full-time position offering competitive compensation and equity options that acknowledge your expertise and potential.
• Direct collaboration with founders at a leading biosensor startup, gaining access to industry specialists and innovative thought leaders.
• Opportunities for personal growth, leadership roles, career advancement, and professional exploration.
• Potential travel opportunities to locations including New York for research and development activities.
• The excitement of working on cutting-edge technologies, influencing strategic choices, and driving innovation within an early-stage, high-performing team.

Additional Information

We encourage candidates who might not perfectly match all criteria but believe they bring unique value to contact us with a brief explanation of their potential contribution.