Process Engineer

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. 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.