Senior Engineer, Molding

Position Summary 

The Sr. Molding Engineer will support the ICU Molding Engineering Department. The Sr. Molding Engineer is responsible for owning and driving injection molding improvements through adherence to established product design, scientific injection molding process, tooling, resin, and equipment. The key responsibility of this position is to lead injection molding resources, manage projects within a product family and take action while adhering to defined procedures. The incumbent will also liaise with the Tooling, Molding, Engineering, Production, Quality, and Maintenance departments.

Essential Duties & Responsibilities

• Functional area tasks and responsibilities
  • Day to day
    • Represent Molding Engineering to identify possible product modifications to improve manufacturability and impact on automation equipment
    • Implement Molding Engineering activities such as scientific injection molding process development, process monitoring, and tool qualifications
    • Lead project timelines for Validation (IQ/OQ/PQ) activities and growth/expansion projects
    • Initiate and manage projects with adherence to program management guidelines as they relate to new/existing molding equipment, tooling, and materials
    • Analyze and spec equipment performance and identify system improvements like vision systems, temperature controllers, robots, and resin analysis
    • Implement Cost Savings - Scrap, De-Cavitation, MUV, DPM, OEE
    • Close coordination with the resources assigned to the product family (tool room, Process Engr, Quality Engr)
    • Own and manage CAPA tasks and deliverables (Corrective and Preventive)
    • Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
  • Long term expectations
    • Lead systematic (Lean / Six Sigma) continuous improvement initiatives like  SMED, Jidoka, DMAIC, 5S and STW)
    • Maintain Product specifications; consult with manufacturing on product non-conformance
    • Perform Design assessments, active participation in Design reviews, Risk Management processes
    • Network with senior internal and external personnel
    • Intellectual Property review and assessment

Knowledge, Skills & Qualifications

• Understanding of strength of materials,  automation, thermoplastic and LSR injection molding, part assembly, fixturing, testing, and process control techniques
• Risk Management-> FMEA generation
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
• Master Molder training / certification or proof of understanding of the Scientific Injection Molding model; process, tooling, part design, materials, and equipment

Education and Experience 

• Bachelor’s degree in Engineering or Technology
• Medical Device Experience is a must
• 8 years combined  experience in the Medical Device or Engineering Industry
• Advanced Degree may substitute for experience

Minimum Qualifications

• Must be 18 years of age

Travel Requirements 

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment 

• While performing the duties of this job, the employee is regularly required to talk or hear. 
• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Work is performed in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time
• Must be able to occasionally move and lift objects of up to 50 lbs

 

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consist