Manufacturing Engineer – Medical Device

Job Title: Manufacturing Engineer

Job Description

This role supports and improves manufacturing operations for regulated medical device products, with a strong focus on process efficiency, product quality, and regulatory compliance. The Manufacturing Engineer works closely with production, quality, and R&D teams to troubleshoot issues, implement process improvements, and support new product introduction from design through validation and full-scale manufacturing.

Required:

• Bachelor’s degree in Engineering
• 5 years in regulated manufacturing (medical device preferred)
• Experience with process validation (IQ/OQ/PQ)
• Experience with CAPA, root cause analysis, and non-conformance investigations
• Knowledge of FDA QSR and/or ISO 13485
• Experience supporting NPI and process improvements
• Proficiency with SolidWorks and Microsoft Office

Preferred:

• Experience with EU MDR
• ERP or QMS system experience

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 methods, ensuring minimal disruption to manufacturing schedules.
• Lead and support process validation activities (IQ, OQ, PQ) for new and existing equipment and processes in accordance with regulatory and internal quality requirements.
• Investigate non-conformances, perform root cause analysis, and drive effective corrective and preventive actions (CAPA) to prevent recurrence.
• Create, maintain, and update manufacturing documentation, including specifications, work instructions, and document change requests (DCRs) and change orders.
• Support new product introduction (NPI) and the transfer of products and processes from R&D into full-scale production, ensuring manufacturability and compliance.
• Partner with Quality to improve inspection methods, measurement techniques, and control plans to ensure adherence to internal and external quality standards.
• Create, implement, and monitor statistical process control (SPC) charts and other process metrics to drive consistency, identify trends, and support continuous improvement.
• Assist with preventative maintenance planning and equipment support to improve equipment reliability and uptime.
• Support equipment validation and equipment maintenance activities in alignment with quality and regulatory expectations.
• Collaborate with supply chain and sourcing functions to support supplier qualification and address supplier-related issues, including long lead time components.
• Contribute to process improvement and continuous improvement initiatives across the manufacturing operation, including document change orders and process change requests.
• Train production personnel on new or updated processes, equipment, and documentation to ensure proper understanding and consistent execution.
• Support quality management system (QMS) activities and documentation, including use of electronic QMS tools, to maintain a robust and compliant quality system.
• Engage in fast-paced problem-solving activities, quickly assessing issues on the manufacturing floor and implementing effective short-term and long-term solutions.

Work Environment

This position is based 100% onsite in a highly regulated manufacturing facility producing medical device products for optometric eye care. The environment is fast-paced and collaborative, with frequent interaction among production, quality, and R&D teams. The role requires a strong, hands-on presence on the manufacturing floor, where issues may arise unexpectedly and must be addressed quickly and systematically. The facility operates under strict FDA QSR, ISO 13485:2016, and EU MDR requirements, supported by formal quality management and ERP systems. The culture emphasizes problem-solving, continuous improvement, and close teamwork to maintain high product quality and reliable operations.

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

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

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)

This is a fully onsite position in Glendora,CA.

This position is anticipated to close on Jun 26, 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.

Salary : $38 - $50