Process Engineer I/II – Extrusion

Applied Medical•Rancho Santa Margarita, CA

5h•Onsite

About The Position

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. The Process Engineer I/II plays a critical role in supporting manufacturing operations by delivering hands-on, solution-oriented engineering support across extrusion processes. This role contributes directly to operational efficiency, product quality, and team member experience by troubleshooting production challenges, optimizing processes, and ensuring consistent execution on the manufacturing floor. The Process Engineer partners closely with operators, technicians, and cross-functional teams to identify root causes, implement improvements, and maintain compliant, well-documented processes.

Requirements

Bachelor’s degree in Mechanical, Manufacturing, Materials, Biomedical Engineering, or related field.
More than one year of relevant experience
Demonstrate strong problem-solving and critical thinking skills, with the ability to break down complex issues and identify root causes.
Comfort working in a hands-on manufacturing environment and engaging directly on the production floor.
Communicate clearly and effectively with both technical and non-technical team members.
Apply strong organizational skills to manage multiple priorities in a fast-paced environment.
Demonstrate attention to detail in both troubleshooting and documentation.
Show willingness to learn and adapt to new processes, equipment, and technologies.
Maintain a high level of accountability, ownership, and follow-through.

Nice To Haves

Experience supporting extrusion or similar manufacturing processes.
Technical writing proficiency, including IQ/OQ/PQ documentation, SOPs, validation protocols, technical reports).
Familiarity with statistical analysis tools, such as Minitab.
Working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Experience in a regulated industry such as medical devices or similar.

Responsibilities

Troubleshoot extrusion production lines and secondary operations to identify and resolve process-related issues.
Analyze manufacturing data to identify trends, root causes, and opportunities for process improvement.
Support and execute process validation activities, including Installation Qualification, Operational Qualification, Performance Qualification (IQ/OQ/PQ) documentation and reporting.
Develop and maintain technical documentation such as standard operating procedures (SOPs), work instructions, process specifications, and troubleshooting reports.
Collaborate closely with operators and technicians to understand real-time production challenges and implement effective solutions.
Spend time both on the manufacturing floor and at a workstation to support hands-on problem solving and documentation.
Support new and existing product builds by ensuring processes are stable, repeatable, and efficient.
Utilize statistical tools to support data-driven decision making.
Ensure adherence to company policies, quality standards, and regulatory requirements.
Contribute ideas for continuous improvement that enhance efficiency, quality, and team member experience.