Automation/ Facilities Engineer

Job Title: Manufacturing Automation Engineer

Job Description

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. You will collaborate closely with equipment suppliers, manufacturing, quality, operations, and R&D teams to successfully launch and optimize new production equipment, while immediately contributing as a hands‑on technical leader with minimal ramp‑up time.

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.
• Support capital equipment planning, including cost control, capex justification, and execution of automation projects.
• Serve as the primary technical liaison with automation integrators and equipment vendors, ensuring technical requirements are fully understood and met.
• Lead the development of RFQs (Requests for Quote), conduct supplier evaluations, and select automation partners based on technical and commercial criteria.
• 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.
• Develop maintenance strategies, spare parts plans, standard operating procedures (SOPs), and training documentation for production and maintenance teams.
• 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.

Essential Skills

• 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.
• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Automation, Electrical Engineering, or a closely related field.
• 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.

Additional Skills & Qualifications

• 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.

Work Environment

This role operates within a high‑volume medical device manufacturing environment that is transitioning from semi‑automated operations to fully automated, high‑speed production. The facility runs fast‑paced lines with sub‑second cycle times and ambitious annual and monthly production volumes, supported by the implementation and qualification of approximately ten new automation systems. You will work closely with cross‑functional teams on the manufacturing floor and in engineering spaces, using tools such as SolidWorks, AutoCAD, precision machining equipment, and precision measuring instruments. The environment emphasizes compliance with FDA, GMP, and ISO 13485 standards, with a strong focus on quality, OEE improvement, and scrap reduction. The role involves periodic travel to automation integrators and equipment vendors for build reviews, FATs, and project milestones. The position offers a performance‑based annual bonus and equity in the form of RSU grants, reflecting a culture that rewards strong contributions and supports growth in a rapidly expanding product line.

Job Type & Location

This is a Permanent position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $120000.00 - $145000.00/yr.

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

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.