Automation/ Facilities Engineer

About the role

This role leads the development, implementation, qualification, and scaling of custom automated manufacturing systems that support a rapidly growing medical device product line. You will drive the transition from labor-intensive assembly processes to highly automated, high-speed production, serving as the technical lead across the full automation lifecycle.

Responsibilities

• Define manufacturing automation strategies for new product introductions and align them with overall production and quality objectives.
• Develop clear and comprehensive User Requirement Specifications (URS) and detailed automation requirements for new equipment and systems.
• Lead equipment concept development, evaluate multiple automation approaches, and select optimal solutions based on performance, cost, and risk.
• Identify technical risks early in the project lifecycle and drive effective mitigation plans throughout equipment development and deployment.
• Serve as the primary technical liaison with automation integrators and equipment vendors, ensuring technical requirements are fully understood and met.
• Support capital equipment planning, including cost control, capex justification, and execution of automation projects.
• Participate in and often lead concept reviews, design reviews, and technical assessments of custom automation equipment.
• Evaluate mechanical designs, risk assessments, equipment layouts, and machine concepts to ensure robust and reliable operation.
• Travel to supplier sites for build reviews, Factory Acceptance Tests (FATs), and key project milestones to ensure equipment meets specifications.
• Support installation and startup of new automated manufacturing equipment on the production floor.
• Lead FAT, Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Partner with Quality and Operations teams to release equipment into production in compliance with applicable standards and procedures.
• Drive issue resolution during equipment commissioning and production launch, ensuring minimal disruption to manufacturing operations.
• Monitor equipment performance, including throughput, yield, scrap, and Overall Equipment Effectiveness (OEE), to ensure targets are achieved.
• Identify bottlenecks and drive equipment and process improvements to increase capacity, improve OEE, and reduce scrap.
• Support change control processes, corrective and preventive actions (CAPA), and validation activities for automated equipment.
• Design or improve fixtures and mechanical equipment using SolidWorks and AutoCAD to support automation and high-precision manufacturing.
• Contribute to continuous improvement initiatives and support high-volume product launches, ensuring systems are ready for future production scale-up.

Requirements

• Minimum of 6+ years of experience in manufacturing automation, equipment engineering, or manufacturing engineering, preferably in a highly regulated industry.
• Proven experience leading custom automation projects from concept and requirements definition through vendor selection, FAT, SAT, qualification, and production release.
• Experience writing or contributing to User Requirement Specifications (URS) and other technical requirements documents.
• Demonstrated experience managing automation vendors, including RFQ development, supplier evaluations, and design reviews.
• Hands-on experience supporting FAT, SAT, equipment installation, and qualification activities (IQ, OQ, PQ).
• Experience with automated or semi-automated assembly, inspection, or test systems in a production environment.
• Ability to read and interpret mechanical drawings, schematics, and pneumatic diagrams.
• Strong project management skills, including cost control, capital project (capex) planning, and risk assessment.
• Strong technical writing and problem-solving skills, with the ability to document and communicate complex technical information clearly.
• Proficiency with SolidWorks and AutoCAD for mechanical design, fixture development, and equipment layout.
• Experience working under FDA, GMP, and ISO 13485 requirements in a medical device or similarly regulated environment.
• Experience designing fixtures or mechanical equipment improvements using SolidWorks and/or AutoCAD.
• U.S. citizenship or permanent residency status, as required for this role.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Automation, Electrical Engineering, or a closely related field.
• Experience with machine vision systems such as Cognex, Keyence, or similar platforms.
• Robotics integration experience, including integrating robots into automated manufacturing cells.
• Exposure to sensors and controls used in automated machinery.
• Familiarity with PLC and HMI systems and their role in automation control and interfaces.
• Experience with continuous improvement initiatives focused on throughput, OEE, and scrap reduction.
• Experience in high-volume manufacturing environments with fast cycle times and demanding throughput targets.
• Experience supporting product launches, including scaling from semi-automated to fully automated production.
• Experience with precision machining and precision measuring equipment used in automated systems.
• Experience conducting or participating in equipment design reviews, risk assessments, and validation activities.
• Ability to collaborate effectively with cross-functional teams, including R&D, Quality, Operations, and external suppliers.
• Comfort working in a fast-paced environment with multiple concurrent automation projects and aggressive timelines.

Skills

• Hands-on experience supporting FAT, SAT, equipment installation, and qualification activities (IQ, OQ, PQ).
• Experience with automated or semi-automated assembly, inspection, or test systems in a production environment.
• Ability to read and interpret mechanical drawings, schematics, and pneumatic diagrams.
• Strong project management skills, including cost control, capital project (capex) planning, and risk assessment.
• Strong technical writing and problem-solving skills, with the ability to document and communicate complex technical information clearly.
• Proficiency with SolidWorks and AutoCAD for mechanical design, fixture development, and equipment layout.
• Experience with machine vision systems such as Cognex, Keyence, or similar platforms.
• Robotics integration experience, including integrating robots into automated manufacturing cells.
• Exposure to sensors and controls used in automated machinery.
• Familiarity with PLC and HMI systems and their role in automation control and interfaces.
• Experience with continuous improvement initiatives focused on throughput, OEE, and scrap reduction.
• Experience in high-volume manufacturing environments with fast cycle times and demanding throughput targets.
• Experience supporting product launches, including scaling from semi-automated to fully automated production.
• Experience with precision machining and precision measuring equipment used in automated systems.
• Experience conducting or participating in equipment design reviews, risk assessments, and validation activities.
• Ability to collaborate effectively with cross-functional teams, including R&D, Quality, Operations, and external suppliers.
• Comfort working in a fast-paced environment with multiple concurrent automation projects and aggressive timelines.

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
Annual equity grant

Pay and Benefits

The pay range for this position is $120,000.00 - $145,000.00/yr.

Workplace Type

This is a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on Jul 17, 2026.