Senior Manufacturing Engineer

Luna Health•San Diego, CA

1d•Onsite

About The Position

Luna Health is a venture-backed medical device startup on a mission to bring insulin automation to the masses. We are developing innovative hardware and software to make life with insulin-requiring diabetes simpler and safer. Our product is a sleep-only automation device that combines a patch pump with a closed-loop algorithm to automatically adjust 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 growing team. This is a hands-on role requiring creativity, collaboration, and organization. Initially, you will own our pilot production line, identifying bottlenecks, improving facility flow, and designing creative solutions for fixturing and equipment. As we approach commercial launch, you will be at the forefront of scaling production, designing and commissioning new automated lines, and building out larger facilities.

Requirements

Bachelor's degree in Mechanical Engineering or a related technical field, or equivalent work experience.
6+ years working hands-on in manufacturing engineering.
Experience working directly with production operators: training them on new processes, troubleshooting issues together, and writing procedures they can follow.
Experience designing fixtures that went into daily use, and maintaining them.
Medical device background with working knowledge of 21 CFR 820 and ISO 13485 is required.
Fluency with good documentation practices, process validations, audits, and traceability is required.
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.
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.

Nice To Haves

Familiarity with small electromechanical assemblies, single-use disposables, wearables, and drug delivery devices is a strong plus.

Responsibilities

Own the Pilot Line, including supervising two production operators, planning production builds and material inventory, forecasting demand, placing orders, and tracking output and quality.
Own the systems that keep the line running, including supplies, records, calibration, and maintenance.
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.