Senior Manufacturing Engineer

Please note that this is an on-site role and you must live within a reasonable commuting distance of the Luna Health site in San Diego, CA.

At Luna Health, we are driven by a singular mission: to bring the transformative power of insulin automation to the masses. We are a venture-backed medical device startup that aims to make life with insulin-requiring diabetes simpler and safer with innovative hardware and software. Our founders are industry veterans with firsthand experience managing diabetes, for themselves or for their child, and a track record of helping people with intelligent, simple-to-use medical products.

We offer a revolutionary approach to nighttime glucose control for people unwilling or unable to use a traditional insulin pump. Part world's smallest patch pump, part first-of-its-kind closed-loop insulin dosing algorithm, our sleep-only automation automatically adjusts insulin doses overnight allowing users to get a good night's sleep and start their days feeling refreshed and worry-free.

We are seeking a Senior Manufacturing Engineer to join our team, reporting to the VP of R&D. This is a hands-on role at a growing company requiring creativity, collaboration, and organization.

Luna has reached clinical studies with a lean, high-performing team, building product on-site on a pilot line staffed by two operators. Initially, you will fully own that line, independently identifying bottlenecks in process and logistics, improving the organization and flow of the facility, and designing creative solutions to fixturing and equipment needs. At lower volumes, this is a key moment to refine workflows and build in quality that will scale.

As we approach commercial launch, production will grow into a full Operations group, and you will be at the forefront of the scale-up: new automated lines to design and commission, and larger facilities to build out.

• Supervise two production operators, including scheduling and build assignments
• Plan production builds and material inventory, forecasting demand, placing orders, and tracking output and quality against the plan
• Own the systems that keep the line running, including supplies, records, calibration, and maintenance, delegating routine execution to operators while remaining accountable for the quality of the result
• Hand off logistics to new dedicated resources over the next 1 - 2 years as pilot production grows into full-scale commercial manufacturing

• Design and build manufacturing fixtures and equipment, collaborating with operators to streamline manufacturing of electromechanical pumps and single-use reservoirs
• Identify and implement process improvements for yield and efficiency
• Source and bring new equipment online, such as heat sealers, adhesive dispensers, and label printers
• Monitor process performance using control charts and other statistical tools
• Develop cost, capacity, and space models to inform equipment decisions and plans for future lines
• Serve as the technical point of contact for the line, troubleshooting build issues, adjusting equipment, and answering operator questions

• Write validation plans and process risk analyses (PFMEAs)
• Write and execute IQ/OQ/PQ protocols and reports for production equipment and processes
  
  Define and execute test method validations
• Support controlled environment room (CER) qualification and environmental monitoring

This role involves creative and diligent engineering, and setting up systems to run smoothly as they scale.

• Bachelor's degree in Mechanical Engineering or a related technical field, or equivalent work experience
• 6+ years working hands-on in…