Medical Device Production Engineer — Lean & GMP

Beta Bionics, Inc.; Irvine (CA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Comprehensive medical and dental

FSA/HSA Plan Options with company con.

401(k) with employer match

Generous vacation and holidays

Job summary

Beta Bionics, Inc. in Irvine, CA is seeking a Production Engineer to design, develop, and implement manufacturing processes for the 3rd and 4th shifts.

The role focuses on efficient, cost-effective and compliant production supporting the iLet Bionic Pancreas. You will monitor process performance, troubleshoot issues, and coordinate with Engineering, Quality, Maintenance, and Supply Chain to achieve production goals and product quality.

Qualifications

• Apply Quality System Regulation and GMP principles.
• Use basic hand tools incl. drills, micrometers, calipers.
• Read mechanical drawings and electrical schematics.
• Operate electrical/mechanical equipment and interpret results.
• Proficient in Microsoft Office and digital tools.
• Work effectively with minimal supervision in cross-functional teams.
• Communicate clearly with stakeholders and maintain attention to detail.

Responsibilities

• Support GMP and company policies.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, OSHA and quality regs.
• Make timely decisions using data and experience.
• Monitor KPIs like yield, scrap, downtime, cycle time; implement corrective actions.
• Develop process improvements to maximize production.
• Lead Lean initiatives and continuous improvement.
• Troubleshoot equipment issues using root cause analysis.
• Coordinate multiple projects to meet timelines in a startup.

Skills

GMP compliance

Quality regulations

Documentation skills

Process analysis

Root cause analysis

Cross-functional teamwork

Education

Bachelor’s in Mechanical/Industrial/Biomedical Engineering

Tools

Micrometers

Calipers

Soldering irons

Drills

Microsoft Office

Job description

Beta Bionics, Inc. in Irvine, CA is seeking a Production Engineer to design, develop, and implement manufacturing processes for the 3rd and 4th shifts.

The role focuses on efficient, cost-effective and compliant production supporting the iLet Bionic Pancreas. You will monitor process performance, troubleshoot issues, and coordinate with Engineering, Quality, Maintenance, and Supply Chain to achieve production goals and product quality.