Automation- Manufacturing Engineer

About the role

This Manufacturing Engineer role supports and improves manufacturing operations for regulated medical device products, with a strong focus on process efficiency, product quality, and regulatory compliance. You will work cross-functionally with production, quality, and R&D teams to troubleshoot issues, implement process improvements, and support new product introduction from design through validation and transfer into production.

Responsibilities

• Provide day-to-day engineering support to production and product development teams to ensure stable, efficient, and compliant manufacturing operations.
• Develop, optimize, and improve manufacturing processes, tooling, and equipment to enhance product quality, increase throughput, and reduce costs.
• Troubleshoot and resolve production issues related to processes, equipment, and fixtures, ensuring minimal downtime and robust corrective actions.
• Lead and support process validation activities (IQ, OQ, PQ) for new and existing manufacturing processes and equipment.
• Investigate non-conformances and lead corrective and preventive actions (CAPA), including root cause analysis and implementation of sustainable solutions.
• Maintain, create, and update manufacturing documentation, including specifications, work instructions, and document change requests (DCRs) and change orders.
• Support new product introduction (NPI) and transfer activities from R&D into production, ensuring processes are validated, documented, and ready for scale-up.
• Partner closely with Quality to improve inspection methods, refine acceptance criteria, and ensure compliance with applicable regulations and standards.
• Create, implement, and monitor statistical process control (SPC) charts and other process metrics to drive consistency, reduce variability, and improve process capability.
• Aid in preventative maintenance planning and equipment support to improve equipment reliability and uptime.
• Support equipment validation and equipment maintenance activities to ensure manufacturing assets operate within validated states.
• Train production personnel on new or updated processes, equipment, fixtures, and documentation to ensure consistent execution on the manufacturing floor.
• Contribute to end-to-end product lifecycle activities from design through validation and manufacturing, ensuring design for manufacturability and smooth transitions.

Requirements

• Bachelor’s degree in Engineering or a related technical field.
• 5+ years of experience in a regulated manufacturing environment, with medical device experience highly preferred.
• At least 2+ years of experience working as a Manufacturing Engineer.
• Working knowledge of FDA Quality System Regulation (QSR).
• Working knowledge of ISO 13485:2016 or similar medical device quality standards.
• Working knowledge of EU Medical Device Regulation (EU MDR 2017/745).
• Hands-on experience with process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience conducting non-conformance investigations and leading CAPA activities.
• Strong understanding of statistical process control (SPC) and process improvement methodologies.
• Proficiency with SolidWorks for fixture and tooling design.
• Proficiency with Microsoft Office, including Excel and Word.
• Experience in process improvement and implementation of change order requests.
• Experience with manufacturing processes, equipment validation, and equipment reliability in a regulated environment.
• Experience working in or supporting a quality management system within a highly regulated industry.

Additional Skills & Qualifications

• Experience with ERP systems; any ERP is acceptable.
• Exposure to quality management systems (QMS), such as Qualio or similar platforms.
• Experience supporting supplier qualification or resolving sourcing issues.
• Exposure to the full product lifecycle from design through validation and manufacturing.
• Experience working with international suppliers and managing long lead times.
• Experience with continuous improvement initiatives and structured problem-solving.
• Experience with document change orders and change control processes.
• Experience with preventive maintenance planning and equipment maintenance coordination.
• Ability to build strong cross-functional relationships with production, quality, R&D, and supply chain teams.

Work Environment

This role is based 100% onsite in a highly regulated manufacturing facility that produces medical device products for optometric eye care. You will work in a fast-paced, hands-on, and highly collaborative manufacturing environment where problem-solving is central to daily activities. When issues arise on the production floor, you are expected to respond quickly, investigate, and drive effective resolutions. The facility operates under strict quality and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR, with robust quality management and documentation practices. You will work closely with production operators, engineers, quality professionals, and R&D teams, using tools such as SolidWorks, Microsoft Office, ERP systems, and QMS platforms to support process development, validation, and continuous improvement.

Job Type & Location

This is a Contract to Hire position based out of Glendora, CA.

Pay And Benefits

The pay range for this position is $38.00 - $50.00/hr.

Requirements

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

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.