Engineer III, Molding

ICU Medical•Salt Lake City, UT

2h•Hybrid

About The Position

The Engineer III, Mold Process role is responsible for supporting Molding Engineering to achieve continuous process and product improvements. This includes implementing scientific injection molding process development, process monitoring, and tool qualifications. The role guides project timelines for Validation (IQ/OQ/PQ) activities, analyzes and specifies equipment performance, and identifies system improvements for equipment such as vision systems, temperature controllers, robots, and resin analysis. The position also focuses on implementing cost savings through scrap reduction, de-cavitation, MUV, DPM, and OEE improvements. It requires close coordination with assigned resources for the product family, including the tool room, Process Engineers, and Quality Engineers. The role assists in completing CAPA tasks and deliverables, works on problems of diverse scope and complexity, and uses creative approaches to solve complex problems. It involves integrating subsystems and components into total systems design, developing specifications from customer requirements, and working on special projects as they arise. The engineer will initiate and manage projects adhering to program management guidelines for new/existing molding equipment, tooling, and materials. Coordination with the Materials Group for vendor assessment and technical information is also a key responsibility. Building productive internal and external relationships, assisting in training new/current employees, and delivering effective communications to promote cross-functional collaboration are essential. The role involves bringing conflicts into the open and resolving them collaboratively, building consensus. Work from home is permitted, with reporting to the Salt Lake City, UT address when not working remotely. Less than 5% domestic and/or international travel is required annually.

Requirements

Bachelor’s degree (or foreign equivalent) in Materials Engineering, Manufacturing Engineering, or closely related field plus Four (4) years of experience in the job offered or a closely related occupation.
Systematic Molding training/certification or proof of understanding of the model; process, tooling, part design, materials, and equipment.
Understanding of strength of materials, automation, thermoplastic and LSR injection molding part assembly, fixturing, testing, and process control techniques.
Experience with risk management, including updating PFMEAs: reviewing and identifying potential issues, assessing their impact, and ensuring the necessary actions are in place to minimize risk.
Experience of Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) and use of Minitab Software for analysis.
Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations.
New tooling, existing tooling, and equipment validation FAT, SAT, IQ, PD, OQ & PQ.
Understanding of the product strategy and can recommend solutions to critical issues.

Responsibilities

Support Molding Engineering for continuous process and product improvements.
Implement Molding Engineering activities such as scientific injection molding process development, process monitoring, and tool qualifications.
Guide project timelines for Validation (IQ/OQ/PQ) activities.
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).
Assist in completion of CAPA tasks and deliverables (Corrective and Preventive).
Initiate and manage projects with adherence to program management guidelines as they relate to new/existing molding equipment, tooling, and materials.
Coordinate efforts with the Materials Group to assess vendors and provide materials technical information.
Build productive relationships internally and externally.
Assist in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.