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About the Role

Level Zero is pioneering next-generation biosensor technology for precise, real-time monitoring of critical endocrine biomarkers. We are seeking driven innovators to join us in pushing the boundaries of biosensing and health tech, making personalized health monitoring a reality for everyone.

Responsibilities

• Own the mechanical design and development of plastic components for a wearable device and pump system.
• Design robust injection molded plastic parts from concept through to production release.
• Produce high-quality 3D CAD models, assemblies and engineering drawings to manufacturing standards.
• Perform tolerance analysis and tolerance stack-ups to ensure robust product performance and manufacturability.
• Create detailed design specifications, engineering requirements and mechanical architecture documentation.
• Develop, refine and execute verification test methods to evaluate product performance and reliability.
• Plan and conduct engineering testing, analyze results and iterate designs based on data.
• Lead mechanical investigations, identify root causes of failures and implement effective design improvements.
• Apply human-centered design practices by conducting human factors studies, usability evaluations, and user research sessions, translating findings into actionable product and design improvements.
• Work closely with external suppliers and manufacturing partners to develop production-ready components.
• Specify and qualify bought-in components and work with suppliers to integrate them into the product.
• Collaborate closely with electronics, systems, quality, manufacturing and industrial design teams.
• Balance technical performance, usability, reliability, manufacturability and cost throughout the design process.
• Contribute to early-stage R&D, collaborating with engineering leadership to define and refine future design iterations.

Requirements

• Master’s degree with 2 - 4 years of industry experience, in biomedical engineering, mechanical engineering or a related discipline.
• Experience designing products with user needs at the center of development.
• Experience designing pump systems, valves, diaphragms or other fluid handling mechanisms.
• Experience designing leak-tight assemblies and developing leak test methods.
• Excellent CAD & drafting skills including complex assemblies and surfacing where appropriate with strong understanding of engineering drawings, GD&T and manufacturing tolerances.
• Experience performing tolerance stack analysis and applying statistical tolerancing where appropriate.
• Experience creating engineering documentation including design specifications and product requirements.
• Experience applying DFM, DFA and DFMA principles.
• Experience working with external suppliers, manufacturers and tooling vendors.
• Experience creating and refining mechanical test methods and verification plans.
• Experience with DFMEA, PFMEA and structured engineering risk management.
• Strong experience designing injection molded plastic components for volume manufacture.
• Experience attending tooling trials, evaluating molded parts and resolving manufacturing issues.
• Proven ability to troubleshoot mechanical failures using structured root cause analysis.
• Understanding of assembly methods including snap fits, heat staking, ultrasonic welding, adhesives or overmoulding.
• Experience with engineering change control, product release processes and PLM systems.
• Strong communication skills and ability to work within multidisciplinary engineering teams.
• Comfortable taking ownership of significant subsystems while working with appropriate technical guidance.
• Experience with design of devices for extraction of dermal interstitial fluid.
• Experience designing wearable medical devices.
• Knowledge of ISO 13485, ISO 14971 or equivalent quality systems.
• Experience with verification and validation (V&V) testing.
• Experience with reliability, environmental, fatigue or life-cycle testing.
• Experience designing precision mechanical mechanisms.
• Experience working with miniature or highly integrated assemblies.
• Experience with rapid prototyping, machining and 3D printing.
• Familiarity with Design of Experiments (DOE) and statistical data analysis.
• Experience supporting pilot builds, manufacturing scale-up and production transfer.
• Basic FEA experience for structural or thermal assessment.
• Prior work in a start-up or small company environment.
• Prior work in medical device development.

Skills

• Mechanical Design
• Plastic Component Design
• Injection Molding
• 3D CAD Modeling
• Engineering Drawings
• Tolerance Analysis
• GD&T
• DFM/DFA/DFMA
• Risk Management (DFMEA, PFMEA)
• Root Cause Analysis
• Assembly Methods
• Engineering Change Control
• PLM Systems
• Human-Centered Design
• Usability Evaluation
• User Research
• Fluid Handling Mechanisms
• Leak Testing
• Verification Testing
• Reliability Testing
• Prototyping
• Machining
• 3D Printing
• DOE
• Statistical Data Analysis
• FEA

Location

• New York

Work Type

• Full-time

Experience Level

• 2 - 4 years industry experience
• Startup experience
• Medical device development experience

Education Level

• Master’s degree

Salary/Compensations

• Competitive salary and equity options

Benefits

• 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
• Work on cutting-edge technology
• Shape strategic decisions
• Drive innovation at an early-stage venture

About the Company

• Level Zero is pioneering next-generation biosensor technology for precise, real-time monitoring of critical endocrine biomarkers.
• Recognized as one of the top 20 startups across all categories worldwide at TechCrunch Disrupt 2024.
• Backed by top-tier organizations like Redalpine, SOSV, and Entrepreneur First.
• Pushing the boundaries of biochemistry and nanotechnology to revolutionize personalized health.
• Founded by two seasoned engineers with extensive experience in R&D, technical innovation, and commercial strategy.
• Mission: to revolutionize 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.

Equal Opportunity

• 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.
• We value integrity, honesty, and transparency.
• We encourage self-starters who love diving into the unknown, collaborating on complex problems, and taking full ownership of results.
• We value open, clear communication and see every piece of feedback as a springboard for growth.
• We are motivated by creating real impact, particularly when it comes to advancing human health.
• We strike a balance between independence and collaboration.
• We encourage confidence in defending ideas, while also valuing respectful, constructive debate.
• We thrive in the dynamic atmosphere of a startup, constantly evolving skill sets and fearlessly applying what we learn.
• 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.