Engineer II, Manufacturing job at ICU Medical in Southington, CT

Engineer II, Manufacturing Southington, CT, United States (Hybrid) Job Description:

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. EDUCATION AND EXPERIENCE 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. SPECIAL REQUIREMENTS: Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time." Required expertise/knowledge includes: 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. ICU Medical, Inc. is an equal opportunity employer. To apply for ICU Medical's Engineer II, Manufacturing position please send resume to: [email protected] Must reference JOB CODE: CT0515AG 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 consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you: Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. Significant US IV solutions manufacturing and supply capabilities. ICU Medical EEO Statement: ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. We are committed to providing equal access and opportunities for all candidates. ICU Medical EEO Policy Statement Know Your Rights: Workplace Discrimination is Illegal Poster ICU Medical CCPA Notice to Job Applicants Apply tot his job Apply To this Job