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. Who we are 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. The role 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. Responsibilities Own the Pilot Line • 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 Manufacturing Process Engineering • 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 Process and Equipment Validation • 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 What you bring This role involves creative and diligent engineering, and setting up systems to run smoothly as they scale. Education and Experience • Bachelor's degree in Mechanical Engineering or a related technical field, or equivalent work experience • 6+ years working hands-on in manufacturing engineering • Has worked directly with production operators: training them on new processes, troubleshooting issues together, and writing procedures they can follow • Has designed fixtures that went into daily use, and maintained them • Medical device background with working knowledge of 21 CFR 820 and ISO 13485 strongly preferred; fluency with good documentation practices, process validations, audits, and traceability is required • Familiarity with small electromechanical assemblies, single-use disposables, wearables, and drug delivery devices is a strong plus Technical Competencies • Clear written and verbal communication with all levels across the organization • Technical writing for manufacturing procedures, formal reports, and written justifications • Proficiency with SolidWorks and mechanical drawings of fixtures and tooling • Strong spreadsheet and organizational skills, applied to production and your own backlog Soft Skills • Comfortable supervising operators: giving clear direction, supporting their needs, and directing their work • Self-motivated and proactive in finding opportunities for improvement • A genuine passion for improving the lives of people with diabetes, and care for the craft of building something they will trust every night • Careful attention to detail, and thorough documentation • Comfortable working in a small, dynamic environment, adaptable to changing priorities and growth What we offer • A no-jerk policy - we seek the best and brightest talent who are fun to work with • Equity - we are early in this journey and you'll be instrumental in Luna's growth • Excellent health benefits - we depend on it ourselves as a team that has or cares for people with diabetes What to expect The first step is to apply for this job on our website. Next, we will schedule a virtual interview with the hiring manager to introduce you to the company and the role. Finally, we will invite you on-site to discuss your experience and meet the team. We are in a hurry to find the right person – not in a hurry to hire – so we will take time getting to know you and making sure that you will be an excellent fit for the work that we are doing. An Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Physical demands The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. • Manual dexterity and near-vision acuity sufficient to handle small components, use hand tools, and work under magnification • Ability to stand, walk, bend, and reach for extended periods while working in laboratory, production, and controlled environment spaces, including donning cleanroom garments • Sit for extended periods of time at a keyboard and mouse • Lift and move up to 25 lbs • Work in a second-story office up a flight of stairs • Hearing and speaking will be required regularly • Specific vision abilities include close and distance vision, depth perception, peripheral vision, and the ability to adjust focus To all Staffing and Recruiting Agencies This posting is only for individuals seeking a job at Luna Health. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific job openings. Luna Health does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to Luna Health. Luna Health is not responsible for any fees related to unsolicited resumes/applications.