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Lead Mechanical Engineer, Molding Processes

2 months ago

Lake Forest, California, United States ICU Medical Full time

Job Title
Manager, Molding Process Engineering

FLSA Status
Exempt

Position Summary
The Molding Engineering Manager will oversee the ICU Molding Engineering Department, which encompasses both liquid injection molding and thermoplastic injection molding. This role requires a hands-on manager who will lead critical projects, prioritize tasks, and drive improvements. The primary responsibility is to identify enhancement opportunities, minimize waste, and mitigate production risks. The manager will provide guidance for thorough mold validations, document best practices, and support both departmental and plant-wide objectives while adhering to established procedures. Collaboration with the Tooling Engineering Department, Project Management, Product Engineering, Production, Quality, and Maintenance teams is essential for production support, engineering initiatives, and continuous improvement efforts.

Essential Duties & Responsibilities

• Manage functional area tasks and responsibilities.

• Lead a team of 8-10 Molding Engineers, exemplifying high-level achievements.

• Ensure project timelines are met, maintain accountability, and publish schedules in collaboration with partnering departments.

• Assume responsibility for new tools from their arrival at the facility until they are transitioned to production, working closely with New Tooling, Sustaining Tooling, and Production leadership.

• Oversee existing tools, focusing on process enhancements, cycle time optimization, and support for engineering-driven changes.

• Serve as a Subject Matter Expert (SME) for molding within the facility, mentoring and cross-training engineers.

• Promote the implementation of best practices throughout the organization.

• Optimize Molding Validation Procedures with input from other functional departments.

• Take a leadership role in Plant Key Performance Indicators (KPIs), Overall Equipment Effectiveness (OEE) improvement, scrap reduction, and contribution margin projects.

• Exercise sound judgment in notifying relevant managers of serious issues related to safety, personnel, or operational deficiencies.

• Coordinate activities to ensure departmental compliance with all regulatory requirements, including FDA, EPA, OSHA, ISO, EEOC, and company policies regarding product manufacturing, documentation, housekeeping, preventative maintenance, calibration, associate training, and safety.

Knowledge, Skills & Qualifications

• Certification or training in Scientific Injection Molding, demonstrating a comprehensive understanding of processes, tooling, part design, materials, and equipment.

• Knowledge of material strength, automation, thermoplastic and LSR injection molding, part assembly, fixturing, testing, and process control techniques.

• Familiarity with Risk Management and Six-Sigma Methodology (including DOE, Process Capability, Gage R&R, etc.), along with a solid understanding of statistics.

• Experience in the Medical Device Industry and knowledge of FDA Quality System Regulations (QSR).

• Proficiency in CAD, MOLD FLOW, and engineering plastics.

• Creative problem-solving skills with the ability to develop scheduling systems within the Molding Processing Department.

• Required experience with capital equipment and customer support.

• Proficient in Microsoft Office Suite.

Education and Experience

• Bachelor's degree in Engineering or Technology.

• A minimum of 15 years of experience in thermoplastic injection molding, with some managerial experience preferred. Candidates may currently hold a senior role in molding engineering or a related field and seek career advancement.

• An advanced degree may substitute for experience.

Minimum Qualifications

• Must be at least 18 years of age.

Travel Requirements

• Typically requires travel less than 10% of the time.

Physical Requirements and Work Environment

• Regularly required to communicate verbally and audibly.

• This position operates in a professional office environment, utilizing standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

• Work is conducted in a clean room environment.

• May require prolonged periods of sitting or standing.

• Ability to occasionally lift and move objects weighing up to 25 lbs.