Manufacturing Engineer I/II – Extrusion

Applied Medical•Rancho Santa Margarita, CA

17d•Onsite

About The Position

The Manufacturing Engineer I/II - Extrusion is a highly hands-on manufacturing engineering role focused on troubleshooting equipment, optimizing extrusion processes, and partnering directly with operators on the production floor. This position spends significant time in manufacturing, driving real-time solutions to production challenges and improving safety, quality, throughout, and scrap performance.

Requirements

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, Industrial Engineering, Materials Engineering, or related discipline.
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

Candidates with direct manufacturing or extrusion experience are strongly preferred.
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 equipment, production lines, and secondary operations to resolve manufacturing issues and improve uptime.
Optimize extrusion processes, equipment performance, and process stability to improve quality, throughput, and efficiency.
Support tooling, machine setups, changeovers, equipment improvements, and capital projects.
Investigate mechanical and process-related causes of variation, downtime, and scrap using root cause analysis and data-driven problem solving.
Partner closely with Production, Maintenance, Quality, operators, and technicians to implement sustainable solutions.
Support new and existing product introductions by developing stable, repeatable, and efficient manufacturing processes.
Develop and maintain technical documentation, including SOPs, work instructions, process specifications, validation protocols, and troubleshooting reports.
Execute process validation activities, including IQ/OQ/PQ protocols and reporting, as required.
Utilize statistical tools and manufacturing data to identify trends and drive continuous improvement initiatives.
Ensure compliance with quality standards, regulatory requirements, and company policies.