Senior Manufacturing Engineer — Pilot Line & Scale-Up (On-Site)

Lunadiabetes; San Diego (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Equity

Excellent health benefits

No-jerk policy

Job summary

Luna Health is seeking a Senior Manufacturing Engineer to own the pilot production line and drive scale-up as we move toward commercial manufacturing. You will design fixtures and equipment, partner with operators, and ensure quality and compliance for electromechanical pumps and single-use reservoirs.

You will lead process validation, write PFMEAs, and establish tools to monitor performance, while coordinating with the R&D team for seamless transition to larger facilities.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field, or equivalent work experience.
• 6+ years hands-on experience in manufacturing engineering.
• Experience training production operators and writing procedures.
• Designed fixtures that saw daily use.
• Medical device background with knowledge of 21 CFR 820 and ISO 13485; documentation, validations, and traceability.
• Familiarity with small electromechanical assemblies, wearables, and drug delivery devices is a plus.

Responsibilities

• Own the Pilot Line: supervise two production operators, plan builds, manage inventory and quality.
• Manufacturing Process Engineering: design fixtures, improve yield, source equipment.
• Process and Equipment Validation: write PFMEAs, IQ/OQ/PQ, test methods, CER qualification.

Skills

Manufacturing engineering

Operator training

Fixtures design

Documentation practices

Regulatory knowledge

SolidWorks

Education

Bachelor's degree in Mechanical Engineering

Equivalent work experience

Tools

SolidWorks

CAD software

Job description

Luna Health is seeking a Senior Manufacturing Engineer to own the pilot production line and drive scale-up as we move toward commercial manufacturing. You will design fixtures and equipment, partner with operators, and ensure quality and compliance for electromechanical pumps and single-use reservoirs.

You will lead process validation, write PFMEAs, and establish tools to monitor performance, while coordinating with the R&D team for seamless transition to larger facilities.