Senior Manufacturing Automation Engineer

Beta Bionics, Inc.•Irvine, CA

1d•Onsite

About The Position

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. The position combines hands-on engineering execution with lifecycle, supplier, and validation leadership from early concept through equipment retirement.

Requirements

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.

Nice To Haves

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.

Responsibilities

Own assigned manufacturing equipment through concept development, supplier selection, procurement, FAT, SAT, installation, qualification, production release, sustaining support, upgrades, and retirement.
Author User Requirements Specifications (URS), equipment acceptance criteria, risk-based test strategies, and supporting technical documentation.
Author and execute commissioning, FAT, SAT, IQ, OQ, and PQ protocols and reports, including deviation and discrepancy resolution.
Lead or participate in equipment and process design reviews with internal stakeholders and external suppliers.
Independently design fixtures, nests, adapters, poke-yoke devices, and mechanical improvements that enhance safety, quality, throughput, ergonomics, and reliability.
Troubleshoot automation, mechanical, controls, and process issues during equipment debug, pilot builds, production launch, and routine manufacturing.
Serve as the primary technical interface with automation vendors, including RFQ development, technical evaluations, design trade-offs, and supplier oversight.
Partner with R&D, Quality, Operations, Maintenance, and automation suppliers to define requirements and ensure equipment meets expectations for fit-for-purpose, maintainability, compliance, and scalability.
Develop and maintain SOPs, work instructions, PM recommendations, spare parts lists, training materials, and change control documentation.
Support root cause analysis, CAPA activities, and continuous improvement initiatives.
Ensure equipment, documentation, and validation activities comply with GMP, FDA, and ISO 13485 and internal quality system requirements.
Provide technical guidance to engineers, technicians, and cross functional partners as needed.