Process Engineer 4

Sanders Industries Holdings•San Clemente, CA

13d

About The Position

IRP Medical is seeking a highly hands-on Process Engineer 4 to drive operational excellence within our specialized manufacturing facility, with focus on Liquid Injection Molding (LIM) operations. This critical role blends core process optimization principles with direct, daily operations support. The Engineer will be responsible for executing, monitoring, and controlling key process variables to ensure repeatable, high-quality production. Success in this position requires being the primary technical resource for troubleshooting floor-level issues and spearheading continuous improvement projects to optimize processes for medical device components in alignment with the IRP Quality Management System. IRP Medical: IRP Medical manufactures high-quality silicone and elastomer components for medical and life-science applications. We are committed to precision, cleanliness, and supporting products that advance patient care. Employees join a team dedicated to excellence, problem solving, and meaningful impact in the healthcare industry.

Requirements

Bachelor’s degree in Mechanical, Industrial, Chemical, Manufacturing Engineering, or related field.
5-7+ years in manufacturing with LIM and automation experience required.
Strong hands-on mechanical aptitude and comfort working on the production floor.
Experience with Microsoft Office (Word, Excel, Teams).
Experience working within ISO-13485 quality systems.
Ability to track, analyze, and act on process data.
Excellent communication, time management, and organizational skills.
Ability to manage multiple priorities and maintain attention to detail under pressure.
High level of professionalism, discretion, and documentation discipline.

Nice To Haves

Medical device, aerospace, defense, or related experience in similar process environments preferred.
Hands-on manufacturing or production engineering experience strongly preferred.
Knowledge of Lean, Six Sigma, or continuous improvement tools a plus.
Experience with PLCs, 3D modeling, and precision measurement tools beneficial.
Experience with Arburg and Engel molding presses.

Responsibilities

Directly support daily LIM manufacturing operations by overseeing the execution of mold setups and production performance on the LIM presses.
Collaborate with toolmakers, engineers, and maintenance to resolve mold and tooling, automation, and other equipment issues.
Work side-by-side with technicians and operators to ensure production follows established standards, work instructions, and safety protocols.
Troubleshoot process and equipment issues on molding machines, automation, and auxiliary equipment in real time to maintain product flow and quality.
Recommend and implement tooling modifications to improve product quality and manufacturability
Provide on-call technical support for critical process and automation issues
Develop and maintain process documentation including setup sheets, parameter sheets, and process control plans for all critical process variables.
Maintain accurate, legible, and complete production and engineering documentation.
Analyze trends to identify deviations and implement corrective actions.
Optimize processes to improve throughput, reduce scrap, and improve consistency and repeatability.
Program, maintain, and troubleshoot robotic automation systems including part removal and secondary automation
Establish standardized procedures to ensure repeatability, efficiency, and compliance with ISO and medical manufacturing requirements.
Participate in cross-functional engineering projects involving new and repeat business.
Assist in project planning, manufacturing handoff, and new product introduction activities.
Assist with mold qualifications, sampling, and new tool launches
Support integration of new automation systems, end-of-arm tooling, and automated inspection systems
Support engineering projects including new equipment implementation and process transfers
Train and mentor new employees, process technicians, and operators on proper procedures and best practices
Provide technical guidance and support to production teams
Promote teamwork, safety, and continuous improvement culture
Identify and implement Lean, 5S, and continuous improvement initiatives targeting process stability, cost reduction, and production efficiency.
Participate in root cause analysis and corrective action implementation.
Lead small-scale improvement projects and contribute to longer-term process roadmaps.
Interface with production, quality, maintenance, planning, suppliers, and customers as needed to support technical activities and business opportunities.
Provide feedback to leadership regarding bottlenecks, quality risks, and improvement opportunities.
Demonstrate a high priority for workplace safety and product quality.
Support compliance requirements including ISO-13485.
Ensure proper handling of specialty chemicals and equipment.
May be required to lift up to 40 lbs.
Perform all other duties as assigned.