Engineer II, Manufacturing

ICU Medical•Southington, CT

2h•Hybrid

About The Position

Responsibilities Immediate expectations: Under the guidance of the Engineering leadership, work to improve performance of manufacturing systems, e.g. OEE improvement (quality, performance and uptime), maintenance needs, MUV and scrap reduction. Support project timelines and milestones and bring them to completion on time and within budget. Assist in completion of CAPA tasks and deliverables (Corrective and Preventive). Use methodical approach for root cause analysis and propose robust technical solutions. Process technical expert for a manufacturing production line. Create and edit documents to support Production. Support initiatives for continuous process and product improvements. Conducts independent analysis and develops solutions to problems. Develops approaches and designs where precedent usually exists. Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design. Receives general project direction. Solicits input from more experienced engineers. Work on special projects as they arise Long term expectations: Initiate and carry out projects with adherence to program-management guidelines. Develop innovative tool design improvements. Develop and characterize processes and summarize technical details. Work with Quality Engineers on qualification activities for new or modified processes and equipment. Assists 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. Work from home permitted. When not working from home, must report to Southington, CT office.

Requirements

Master’s degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management, or closely related field (or foreign equivalent) OR a Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management, or closely related field (or foreign equivalent) plus two (2) years of experience in the job offered or closely related occupation.
Understanding of automation, plastic injection molding, plastic extrusion, part assembly, fixturing and testing
Understanding process control techniques including Statistical Process Control and Minitab data analysis
Experience with Six-Sigma Methodology (Design of Experiments, Process Capability, and Gage Repeatability and Reproducibility)
Knowledge of the Medical Device Industry and familiarity with FDA Quality System Regulations
Proficiency in SolidWorks, AutoCAD, and Agile PLM (manufacturing bills of materials and routings)
Mechanical understanding and tool design experience including fixture design, tooling settings and equipment deployment
Technical writing competency (work instruction and detailed equipment technical documents)
Process Validations including Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Test Method Validation
Project Management of capital projects including Capital Expenditure submission with technical and financial justification, managing timelines for equipment validation and integration, and ensuring compliance with regulatory standards.

Responsibilities

Improve performance of manufacturing systems, e.g. OEE improvement (quality, performance and uptime), maintenance needs, MUV and scrap reduction.
Support project timelines and milestones and bring them to completion on time and within budget.
Assist in completion of CAPA tasks and deliverables (Corrective and Preventive).
Use methodical approach for root cause analysis and propose robust technical solutions.
Process technical expert for a manufacturing production line.
Create and edit documents to support Production.
Support initiatives for continuous process and product improvements.
Conducts independent analysis and develops solutions to problems.
Develops approaches and designs where precedent usually exists.
Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.
Receives general project direction.
Solicits input from more experienced engineers.
Work on special projects as they arise
Initiate and carry out projects with adherence to program-management guidelines.
Develop innovative tool design improvements.
Develop and characterize processes and summarize technical details.
Work with Quality Engineers on qualification activities for new or modified processes and equipment.
Assists 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.