Manufacturing Process Engineer

Woodland, CA | Full-Time | On-Site

About the Role:

We are seeking an experienced Manufacturing Process Engineer to support a growing medical device manufacturing operation specializing in silicone component manufacturing. This role is responsible for developing, validating, optimizing, and sustaining manufacturing processes that support high-quality production while ensuring regulatory compliance and operational efficiency.

The ideal candidate has extensive experience with silicone injection molding, along with a strong background in process validation, medical device manufacturing, and continuous improvement. This position partners closely with Manufacturing, Quality, Engineering, and Operations to improve process capability, reduce variability, and successfully launch new products into production.

Silicone injection molding experience is required for this position.

Responsibilities:

• Develop, optimize, and validate manufacturing processes for silicone injection molding and other silicone fabrication operations.
• Lead process development activities from concept through production, including equipment qualification and process validation.
• Create and execute validation protocols including IQ, OQ, PQ, process challenges, and Design of Experiments (DOE) to establish robust manufacturing processes.
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) to maintain process control and product quality.
• Troubleshoot molding processes and manufacturing issues to improve yield, reduce scrap, and maximize equipment utilization.
• Develop and document manufacturing processes, work instructions, SOPs, routers, Bills of Materials (BOMs), and manufacturing documentation through the Quality Management System.
• Design and implement process improvements that increase manufacturing efficiency, improve product quality, and reduce production costs.
• Collaborate with Quality Engineering on deviation investigations, root cause analysis, CAPA activities, and validation projects.
• Support new product introductions by developing manufacturing processes, fixtures, tooling, and assembly methods.
• Partner with Production to ensure manufacturing processes consistently meet production schedules and customer requirements.
• Work with tooling vendors, equipment suppliers, and internal engineering teams to implement new equipment and manufacturing technologies.
• Support equipment qualifications, process transfers, and manufacturing scale-up activities.
• Train manufacturing personnel on new processes, equipment, and standardized work instructions.
• Participate in Lean Manufacturing, Six Sigma, and continuous improvement initiatives to improve operational performance.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Chemical Engineering, Biomedical Engineering, or a related technical discipline.
• Minimum of 8 to 10 years of manufacturing process engineering experience in a production environment.
• Required experience with silicone injection molding in a manufacturing environment.
• Experience developing and validating manufacturing processes for silicone medical device components or similar precision molded products.
• Strong knowledge of process validation, IQ, OQ, PQ, DOE, statistical process control, and manufacturing process qualification.
• Experience supporting regulated manufacturing environments, preferably medical device manufacturing operating under FDA Quality System Regulations, cGMP, and ISO 13485.
• Experience with process optimization, troubleshooting, root cause analysis, and corrective actions.
• Proficiency with SolidWorks, AutoCAD, or similar CAD software.
• Strong understanding of tooling, fixtures, automation, and manufacturing equipment.
• Excellent analytical, communication, and project management skills.

Desired Qualifications:

• Experience with additional silicone manufacturing processes including extrusion, calendaring, compression molding, liquid silicone rubber (LSR) molding, assembly, or secondary manufacturing operations.
• Previous validation engineering experience within the medical device industry.
• Experience leading new product introductions and manufacturing transfers.
• Lean Manufacturing or Six Sigma certification.
• Experience developing custom fixtures and production tooling.
• Knowledge of statistical analysis software such as Minitab.
• Experience mentoring junior engineers and manufacturing personnel.