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Senior Manufacturing Engineer
Luna Health
San Diego, USA
Full-time
Mid · 6+ years experience
Onsite
Discovered 1 weeks ago
solidworks
Key Skills for This Role
solidworks
Full Job Posting
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.
- 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
- 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
Education and Experience
- 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
Preferred Qualifications
- 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
About Luna Health
Software & SaaS6 employeesFounded 2023
AI-native clinical operating system for healthcare providers and multi-provider clinics in Latin America and North America.
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