Automation Engineer

Job Title: Manufacturing Automation Engineer

Job Description

This Manufacturing Automation Engineer role leads the development, implementation, qualification, and scaling of custom automated manufacturing systems for a rapidly growing medical device product line. You will drive the transition from labor-intensive assembly processes to highly automated, high-speed production, acting as a hands-on technical leader across the full automation lifecycle. In close collaboration with equipment suppliers, manufacturing, quality, operations, and R&D, you will define automation strategies, deliver robust production equipment, and continuously improve performance in a highly regulated environment.

Responsibilities

• Define manufacturing automation strategies for new product introductions, focusing on transitioning from semi-automated and manual processes to fully automated, high-speed production.

• Develop and maintain User Requirement Specifications (URS) and detailed automation requirements for new equipment and systems.

• Lead custom automation projects from concept development and requirements definition through vendor selection, FAT/SAT, qualification, and production release.

• Lead equipment concept development, evaluate multiple automation approaches, and select optimal solutions based on technical feasibility, risk, cost, and scalability.

• Identify technical risks early in the project lifecycle and drive comprehensive mitigation plans throughout equipment development and deployment.

• Support capital equipment planning and execution, including participation in capex decisions, cost control, and justification for new automation investments.

• Serve as the primary technical liaison with automation integrators and equipment vendors, ensuring alignment with URS and regulatory requirements.

• Lead RFQ development, supplier evaluations, and vendor selection for custom automation equipment and related systems.

• Participate in and often lead concept reviews, design reviews, and technical assessments of mechanical designs, layouts, risk assessments, and machine concepts.

• Evaluate mechanical designs, precision machining approaches, and precision measuring strategies to ensure robust and repeatable equipment performance.

• Travel to supplier sites for build reviews, FATs, and key project milestones, providing hands-on technical input and resolving issues in real time.

• Support installation and startup of new automated manufacturing equipment on the production floor.

• Lead FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) activities to ensure equipment readiness for production.

• Partner closely with Quality and Operations teams to release equipment into production in compliance with FDA, GMP, and ISO 13485 requirements.

• Drive issue resolution during commissioning and production launch, troubleshooting mechanical, automation, and process issues to minimize downtime.

• Monitor equipment performance, including throughput, yield, scrap rates, and OEE metrics, and use data to identify bottlenecks and improvement opportunities.

• Identify and implement equipment improvements to increase capacity, improve OEE, reduce scrap, and support future production scale-up to very high volumes and sub-second cycle times.

• Support and execute change control, CAPA, and validation activities related to automation equipment and process changes.

• Develop maintenance strategies, spare parts plans, standard operating procedures (SOPs), and training documentation for operations and maintenance teams.

• Collaborate with R&D to understand product design, determine optimal assembly sequences, and decompose the process into equipment modules and stations.

• Own the full lifecycle of multiple pieces of custom automation equipment, from initial concept and URS through long-term optimization in high-volume production.

• Contribute to continuous improvement initiatives in high-volume manufacturing environments, including implementation of sensors, controls, and advanced automation technologies.

• Support product launches by ensuring automation readiness, equipment robustness, and alignment with forecasted production volumes.

Essential Skills

• At least 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 through production release, including URS development, vendor selection, FAT, SAT, and qualification.

• Experience writing or contributing to User Requirement Specifications (URS) and translating product and process needs into clear equipment requirements.

• Demonstrated experience managing automation vendors and integrators, including reviewing equipment designs and ensuring alignment with technical and regulatory requirements.

• 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 manufacturing environment.

• Ability to read and interpret mechanical drawings, schematics, and pneumatic diagrams to support design reviews and troubleshooting.

• Strong project management skills, including planning, risk management, cost control, and coordination of multiple stakeholders.

• Strong technical writing skills for URS, validation documentation, SOPs, and technical reports.

• Strong problem-solving skills with a track record of resolving complex mechanical and automation issues in production environments.

• Proficiency with SolidWorks for mechanical design and fixture development.

• Proficiency with AutoCAD for layouts, mechanical documentation, and equipment modifications.

• Experience in automation, equipment engineering, or manufacturing within a highly regulated industry such as medical devices.

• Working knowledge of FDA, GMP, and ISO 13485 requirements as they apply to automated manufacturing equipment and processes.

• Experience designing fixtures or mechanical equipment improvements using SolidWorks and/or AutoCAD.

• Experience with custom automation development from concept through FAT, SAT, and qualification.

• Experience with RFQ processes, vendor selection, and capital projects (capex) related to automation equipment.

• Familiarity with precision machining and precision measuring equipment as applied to automated machinery.

• Comfort working in high-volume manufacturing environments with aggressive throughput and OEE targets.

Additional Skills & Qualifications

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

• Experience with machine vision systems such as Cognex, Keyence, or similar platforms for inspection and guidance.

• Experience integrating robotics into automated manufacturing systems.

• Exposure to sensors and controls used in automated equipment.

• Familiarity with PLCs and HMIs for equipment control, troubleshooting, and optimization.

• Experience supporting product launches and ramping production from manual or semi-automated processes to fully automated systems.

• Experience leading or contributing to continuous improvement initiatives in high-volume manufacturing.

• Experience developing and implementing risk assessments for automated machinery.

• Experience in high-speed, high-volume production environments with sub-second cycle times.

• Experience working on capital equipment projects, including justification, budgeting, and execution.

• Comfort working with cross-functional teams including R&D, Quality, Operations, and external vendors.

• Ability to travel to supplier sites for design reviews, build reviews, FATs, and project milestones as needed.

Work Environment

The role is based in a high-volume medical device manufacturing environment that is rapidly transitioning from semi-automated and manual processes to fully automated production. The facility operates at very high throughput, with aggressive production forecasts and sub-second cycle times, supported by approximately ten new automation systems and additional equipment planned for future scale-up. You will work closely with cross-functional teams on the production floor and in engineering spaces, using tools such as SolidWorks, AutoCAD, precision measuring equipment, and advanced automation technologies including machine vision, robotics, sensors, and PLC/HMI-based controls. The environment emphasizes compliance with FDA, GMP, and ISO 13485 standards, robust validation practices, and continuous improvement of OEE, scrap reduction, and equipment reliability. The culture supports growth, with a strong pipeline of R&D projects, new product introductions, and ongoing investments in automation to support long-term production scaling.

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 - $150000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Sep 25, 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 View email address on click.appcast.io 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.