Molding Process Engineering Manager

At Röchling Medical, we're united by a shared purpose: improving lives through innovation in health. As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives.

The Molding Process Engineering Manager leads and owns all injection molding process engineering and validation activities, including process development, troubleshooting, and equipment optimization. This role establishes and standardizes robust molding processes, ensures production readiness of tooling and equipment, and drives continuous improvement in quality, OEE, and overall operational performance through best practices and scientific molding principles.

Lead, develop, and manage a team of Molding Process Engineers and Molding Setup Technicians, ensuring technical capability, performance, and alignment with organizational goals.

• Lead injection molding process development, standardization, and optimization to ensure robust, repeatable, and efficient production using scientific molding principles and best practices.
• Own process validation and production readiness, including mold trials, parameter development, and IQ/OQ/PQ execution, ensuring quality, compliance, and manufacturability.
• Provide technical leadership and escalation support for molding, tooling, and automation challenges, guiding engineers and technicians in structured troubleshooting and continuous improvement.
• Partner cross-functionally with Quality, Tool Engineering, Toolroom, Manufacturing, and NPI to align part design, tool design, quality requirements, and production processes, including DFM reviews and tool sign‑off.
• Drive operational excellence initiatives, including OEE improvement, downtime reduction, and application of lean manufacturing and 5S principles within molding operations.
• Lead evaluation, selection, and implementation of molding equipment, presses, automation, and peripherals, including lifecycle assessment and replacement planning to support NPI, capacity expansion, and cost reduction.
• Manage molding‑related capital and expense budgets, including equipment, tooling, automation, and technical training investments.
• Establish and maintain standardized process documentation, including setup sheets, control plans, troubleshooting guides, and work instructions.
• Lead investigation and resolution of quality issues, partnering with Quality on NCRs, CAPAs, and recurring process defects.
• Serve as the primary process engineering interface for customers, communicating technical status, risks, and improvement plans related to molding processes.

• Demonstrated expertise in injection molding process development, optimization, and technical leadership.
• Strong command of scientific molding principles, including data‑driven process characterization, control, and optimization.
• Deep working knowledge of injection molding machines, tooling, and peripheral equipment, including automation interfaces.
• Proven ability to lead, communicate, and solve complex technical problems in a manufacturing environment.
• Ability to prioritize and execute multiple initiatives while driving projects to completion in a fast‑paced operation.
• Proficiency in Microsoft Office, Minitab, Solid Works, and other relevant engineering and statistical analysis tools.

Bachelor’s degree in Plastics Engineering or a related engineering discipline. Minimum of 7 years of experience in injection molding, including at least 2 years in a leadership role. Advanced technical experience in injection molding and scientific molding certification preferred. Experience with lean manufacturing and continuous improvement methodologies.

• Ability to work for extended periods at a computer and in a manufacturing environment.
• Ability to occasionally lift up to 30 pounds.
• Visual acuity required for inspections, color differentiation, and review of electronic and printed documentation.

Manufacturing environment requiring appropriate personal protective equipment (PPE), including eye protection. Exposure to elevated noise levels requires hearing protection. Work in a cleanroom environment, including gowning and adherence to sanitation requirements.