Senior Manufacturing Engineer - Lean Leader (Med Devices)

Beta Bionics, Inc.; Irvine (CA); On-site; USD 110,000 - 135,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental coverage

FSA/HSA with company contribution

401(k) with employer match

Paid vacation and holidays

Job summary

Beta Bionics, Inc. in Irvine, CA is seeking a Sr.

Manufacturing Engineer to lead training, development, and education of junior engineers, applying Lean manufacturing and Agile Scrum to improve processes, productivity, and product quality. The role emphasizes cross‑functional collaboration, root‑cause analysis, and the ability to read mechanical drawings, with responsibilities spanning design qualification, tooling, and fixture development for scalable production.

Qualifications

• Ability to apply Quality System Regulations (QSRs/GMPs).
• Proficient with basic hand tools (drills, soldering irons, micrometers, calipers).
• Able to operate electrical and mechanical equipment and interpret results.
• Able to read mechanical drawings and electrical schematics.
• Proficient in Microsoft Office and online applications.
• Expert proficiency in SolidWorks and CAD drawings.
• Able to work well in a cross‑functional team.

Responsibilities

• Support quality system compliance and regulatory requirements (QSRs/GMPs, FDA regulations).
• Mentor Jr. personnel and lead tasks to achieve goals.
• Ensure adherence to regulatory and internal policies.

Skills

Quality systems & GMP compliance

CAD drawing in SolidWorks

Reading drawings & schematics

Microsoft Office proficiency

Cross-functional collaboration

Education

Bachelor’s Degree in Mechanical or Manufacturing Engineering

Tools

Drills

Soldering irons

Micrometers

Calipers

Electrical testing equipment

Job description

Beta Bionics, Inc. in Irvine, CA is seeking a Sr.

Manufacturing Engineer to lead training, development, and education of junior engineers, applying Lean manufacturing and Agile Scrum to improve processes, productivity, and product quality. The role emphasizes cross‑functional collaboration, root‑cause analysis, and the ability to read mechanical drawings, with responsibilities spanning design qualification, tooling, and fixture development for scalable production.