Senior Manufacturing Automation Engineer

Summary/Objective

The Senior Manufacturing Automation Engineer is a technical owner and subject-matter expert for automated and semi-automated manufacturing systems in a regulated medical device production environment. This role leads high-impact automation initiatives that improve safety, quality, throughput, cost, and scalability, while serving as a key technical interface between R&D, Operations, Quality, and equipment suppliers.

Essential Duties and Responsibilities

• Equipment Lifecycle Ownership
• Design, Validation, and Documentation
• Technical Execution and Troubleshooting
• Cross-Functional and Supplier Leadership
• Sustaining, Compliance, and Continuous Improvement

Required Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Electrical, Mechatronics, or related engineering discipline.
• 7+ years of experience in automation, equipment engineering, or manufacturing engineering in a regulated medical device or highly regulated manufacturing environment.
• Demonstrated experience owning manufacturing equipment through installation, qualification, sustaining support, and change management.
• Experience authoring URS, technical requirements, and validation protocols.
• Experience with automated or semi-automated assembly, test, or inspection equipment.
• Ability to read and interpret mechanical drawings, electrical schematics, and pneumatic diagrams.
• Strong troubleshooting, technical writing, project management, and cross-functional communication skills.
• Working knowledge of FDA regulations, GMP, ISO 13485, risk management, and change control.
• Proficiency in SolidWorks.

Desired Skills

• Familiarity with setup, calibration, and basic programming of machine vision systems (e.g., Cognex or Keyence) for defect detection, part orientation, and presence/absence verification.
• Experience designing fixtures or mechanical equipment improvements using CAD software.
• Experience with robotics, servo motion, pneumatic systems, sensors, or PLC/HMI-controlled equipment.
• Familiarity with PM development, spare parts strategy, calibration, and long-term equipment lifecycle management.

Why You'll Love This Role

You will own complex and impactful automation in a rapidly scaling medical device manufacturing environment, influence manufacturing and equipment strategy, and see your work directly improve quality of life for people living with diabetes. This role offers end-to-end ownership, meaningful technical challenges, and the opportunity to make a visible impact on critical medical devices.

Work Environment and Personal Protective Equipment

This role operates in a professional office and manufacturing environment. Personal protective equipment may be required for laboratory, cleanroom, or production floor activities.

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hands to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, see, talk, or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. The employee must occasionally lift and/or move up to 40 pounds. Wears personal protective equipment as required.

Travel

This position may require up to 20 percent travel depending upon business needs.

Location

This position is based out of our office in Irvine, California.

Salary Range

$115,000 - $145,000 - Compensation is commensurate with experience and level

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.