Process Engineer

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.

• 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.

• 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.

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 Lake Forest, CA.

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

This is a fully onsite position in Lake Forest,CA.

This position is anticipated to close on Apr 22, 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $100,000 - $125,000