Process Engineer

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 expereince in chemistry to support material and formulation considerations in device manufacturing.

Key Responsibilities:

Location:

Lake Forest, CA

• Develop, optimize, and scale manufacturing processes for medical devices, ensuring consistency, efficiency, and compliance with regulatory standards (ISO 13485, 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.

Skills Manufacturing engineering, Process improvement, chemistry, Medical device, Process engineering, Engineering, New product introduction, Npi, Manufacturing process, gamma, ethylene, autoclave, coating, adhesive, polymer, polymer chemistry, lean manufacturing, six sigma, chemical processing, chemical manufacturing, chemical process equipment, sterilization, New product development, R&d Top Skills Details Manufacturing engineering,Process improvement,chemistry Additional Skills & Qualifications Lean Six Sigma or Lean Manufacturing Experience with Coatings, adhesives or polymer based medical devices Experience Level Intermediate Level Job Type & Location This is a Permanent position based out of San Clemente, CA. Pay and Benefits The pay range for this position is $130000.00 - $150000.00/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 11, 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.