Process Engineer

Actalent • San Clemente, CA • 15h ago

Job Title: Process Engineer

Job 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, expereince 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 May 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.

PwC • Irvine, CA • 2d ago

IT & Engineering

Specialty/Competency: Data, Analytics & AI Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 80% At PwC, our people in data and analytics engineering focus on leveraging advanced technol...

2d ago

Go to Apply

AI & GenAI Data Scientist - FS- Director

PwC • Irvine, CA • 3d ago

IT & Engineering

3d ago

Go to Apply

Systems Software Engineer

Danaher Corporation • Carlsbad, CA • 3d ago

IT & Engineering

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems , one of Danaher's ( https://danaher.com/our-businesses )...

3d ago

Go to Apply

Principal Mechanical Engineer - Optronics (Onsite)

RTX Corporation • Carlsbad, CA • 3d ago

IT & Engineering

Date Posted: 2026-05-07 Country: United States of America Location: US-CA-CARLSBAD-582 ~ 2752 Loker Ave W ~ LOKER Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship...

3d ago

Go to Apply

Electrical Engineering Professional

Jacobs • Irvine, CA • 4d ago

IT & Engineering

At Jacobs, we do not settle - always looking beyond to raise the bar and deliver with excellence. We apply our expertise and knowledge as we?look into?the future with great optimism and focus. We don't settle until we gi...

4d ago

Go to Apply

Lead Electrical Engineer - Buildings

WSP USA • Irvine, CA • 4d ago

IT & Engineering

WSP is currently initiating a search for a Lead Electrical Engineer to join our Property & Buildings team in California. This position may be based out of any WSP office in California . This is an exciting opportunit...

4d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)