Senior Manufacturing Automation Engineer (Medical Device)

Location: Onsite in Irvine, California, United States; up to 20% travel may be required.

Salary: $115,000–$145,000 per year, commensurate with experience and level.

Company

hirify.global is a medical technology company developing the iLet Bionic Pancreas and other type 1 diabetes management solutions.

What you will do

• Own manufacturing equipment through concept development, supplier selection, procurement, FAT, SAT, installation, qualification, production release, sustaining support, upgrades, and retirement.
• Author and execute URS, acceptance criteria, risk-based test strategies, commissioning, FAT, SAT, IQ, OQ, and PQ documentation.
• Design fixtures, nests, adapters, poke-yoke devices, and mechanical improvements for safety, quality, throughput, ergonomics, and reliability.
• Troubleshoot automation, mechanical, controls, and process issues during equipment debug, pilot builds, production launch, and routine manufacturing.
• Lead technical collaboration with automation vendors and partner with R&D, Quality, Operations, Maintenance, and suppliers.
• Maintain SOPs, work instructions, preventive maintenance recommendations, spare parts lists, training materials, and change control documentation while supporting CAPA and continuous improvement.

Requirements

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

Nice to have

• Experience with machine vision systems such as Cognex or Keyence.
• 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 preventive maintenance development, spare parts strategy, calibration, and equipment lifecycle management.

Culture & Benefits

• Mission-driven, collaborative environment with significant ownership and technical impact.
• Work across office and manufacturing environments; personal protective equipment may be required in laboratory, cleanroom, or production areas.
• Medical and dental coverage.
• FSA and HSA options with an annual company HSA contribution.
• 401(k) program with employer match, vacation accrual, and paid holidays.