Process Engineer

Actalent • San Clemente, CA • 5h ago

Job Title: Process EngineerJob Description

We are seeking a motivated Process Engineer to support the development, optimization, and scale-up of manufacturing processes for medical devices. The ideal candidate will have a strong engineering foundation, experience in process improvement, and a background in chemistry to support material and formulation considerations in device manufacturing.

Responsibilities

Develop, optimize, and scale manufacturing processes for medical devices, ensuring consistency, efficiency, and compliance with regulatory standards (ISO, FDA 21 CFR Part 820).

Conduct root cause analysis and implement corrective/preventive actions for process deviations and non-conformances.

Collaborate with R&D, Quality, and Manufacturing teams to transfer new products from development to production.

Evaluate materials, formulations, and chemical interactions relevant to device performance and stability.

Design, implement, and validate sterilization processes (e.g., gamma, ethylene oxide, autoclave) for medical devices.

Generate and maintain detailed process documentation, including batch records, SOPs, and process validation protocols.

Lead small projects or process improvement initiatives, employing Lean, Six Sigma, or other continuous improvement methodologies.

Support process qualification, validation, and risk assessments in compliance with regulatory requirements.

Train production staff on new processes, sterilization techniques, or process improvements.

Essential Skills

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Materials Science, Chemistry, or a related technical field.

2-4 years of process engineering experience in a regulated industry (medical device, pharmaceutical, or equivalent).

Demonstrated experience with process development, optimization, and validation (IQ/OQ/PQ) in a manufacturing environment.

Practical experience with at least one sterilization method (e.g., ethylene oxide, gamma irradiation, or autoclave) and associated validation activities.

Strong analytical, problem-solving, and communication skills, with the ability to work cross-functionally.

Additional Skills & Qualifications

Experience with statistical analysis tools (e.g., Minitab) or process modeling/simulation software.

Exposure to regulatory submissions and design transfer activities.

Experience with coatings, adhesives, or polymer-based medical devices.

Experience with analytical testing using HPLC, Horiba, GC, FTIR.

Continuous improvement methodologies.

Work Environment

The position is located at a medical device manufacturing site in Lake Forest and San Clemente. The company is dedicated to improving patient outcomes through innovative and high-quality products, fostering a culture of collaboration, continuous improvement, and scientific rigor.

Job Type & Location

This is a Permanent position based out of San Clemente, CA.

Pay and Benefits

The pay range for this position is $100000.00 - $125000.00/yr.

Internal employee benefits include but are not limited to: Medical Dental Vision PTO, Holiday CA Sick Pay Employee stock options Additional employee benefit options

Workplace Type

This is a fully onsite position in San Clemente,CA.

Application Deadline

This position is anticipated to close on Apr 20, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

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