Staff Mechanical Engineer

Luna Health•San Diego, CA

4d•Onsite

About The Position

Luna Health is a venture-backed medical device startup developing insulin automation hardware and software, including a sleep-only system that automatically adjusts insulin doses overnight. The Staff/Principal Mechanical Engineer will report to the VP of R&D as a hands-on technical partner and serve as the central integrator for the hardware design. The role brings together user needs, risk analysis, mechanics, electronics, and industrial design to create a cohesive product. Luna’s product has reached clinical studies. The engineer will own how the full hardware system comes together and carry it through verification and into volume manufacturing, building manufacturability and reliability into the design from the beginning. The role combines systems-level thinking about user interaction, risk mitigation, electronics integration, and product form with hands-on detailed design, analysis, testing, and debugging. This is an on-site position. The employee must live within a reasonable commuting distance of Luna Health’s site in San Diego, California.

Requirements

Bachelor’s degree in Mechanical Engineering or a related technical field.
At least 8 years of mechanical product design experience, including experience with medical devices or other safety-critical systems.
Track record of taking a product from design through verification and into volume manufacturing, with manufacturability considered early.
Proven experience serving as the technical integrator across mechanical, electrical, industrial design, and user requirements for a complex hardware product.
Experience designing mechanisms and moving assemblies.
Deep hands-on expertise designing molded and machined parts and assemblies.
Advanced use of tolerance analysis as a design tool.
Working knowledge of design controls, verification and validation, risk analysis, biocompatibility, sterilization, and human factors.
Ability to work across electrical, industrial design, regulatory, quality, and manufacturing disciplines.
Strong organization and communication skills to coordinate projects and budgets and align stakeholders.

Nice To Haves

Master’s degree.
Experience designing compact motorized electromechanical devices.
Experience mentoring engineers or leading small projects.

Responsibilities

Serve as the central integrator of the hardware system, ensuring mechanisms, electronics, motion, fluidics, packaging, and user experience come together as one cohesive product.
Translate user needs into design requirements and decisions, working with industrial design to create a functional and attractive product.
Lead and contribute to risk analysis and use findings to drive early design decisions and mitigations.
Own the fit, integration, and interaction of electronics subassemblies within the mechanical system in collaboration with electrical engineering.
Design molded and machined assemblies and use tolerance analysis as a core design tool.
Analyze, test, and resolve complex system-level issues using engineering fundamentals and hands-on problem-solving.
Collaborate with industrial design to deliver an elegant, user-centered product.
Work with regulatory and quality teams on design controls, verification and validation, risk analysis, biocompatibility, sterilization, and human factors.
Partner with manufacturing engineering to transfer designs into production and continuously improve them.
Work independently to gather latent requirements and develop well-reasoned plans.
Coordinate projects, timelines, and budgets.
Communicate across functions and escalate issues when needed.
Mentor junior engineers and share experience as the team grows.