Senior Manufacturing Engineer

Luna Health•San Diego, CA

3d•Onsite

About The Position

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.

Requirements

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
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

Responsibilities

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