<p>Position Summary</p> <p>The primary function of this job is to execute plastic components strategies and initiatives for ICU Medical Device products. These strategies will be defined by the Operations team with inputs from the stakeholders.</p> <p>Stakeholders include: PMOs, R&D, Operations, Procurement, and Supplier Quality.</p> <p>This position will execute tooling, equipment, and manufacturing processes relative to plastics.</p> <p>Represents the Advanced Manufacturing Engineering (AME) business unit on projects. Routinely provides expert analysis and advice regarding manufacturing process to senior business unit management. Position could range from Contract Engineer to full time Employee depending on the business needs at the time of hire.</p> <p>Essential Duties & Responsibilities</p> <p>Provide expert technical guidance and support to R&D in the design and implementation of high quality new products and processes, through Reverse Engineering, DFM, DFA, Mold Flow, Dimensional analysis, DOE, and other problem solving tools.</p> <ul> <li>Work with R&D Materials Engineering to ensure materials used in production are producible, high quality, common and cost effective. </li><li>Execute implementation of best practices established by industry and the Advanced Manufacturing Engineering team. </li><li>Develops and implements AME practices, optimizing solutions by considering the effect of any change to a part, or on other parts or assemblies regarding tooling, process or assembly. Understand design concepts of the final product, coach other engineering disciplines and help update design standards and best practices through the design cycle. </li><li>Evaluate existing tooling and processes. Identify when obsolete and needing repair, Refurbished, or Replaced. Identify when truly tooling or process, vs competence of supplier </li><li>Analyzes and executes make cost vs buy cost, and which is most appropriate use of both human and capital resources. </li><li>In support of the previous, Implement high quality validated Tools, Equipment, and Processes at suppliers and in our operations facilities. </li><li>Identifies, creates, and leads best practices for TMV, FAT, IQ, OQ, and assist PML through the PQ process, possibly both component and assembly level </li><li>Additional duties as assigned </li></ul> <p>Longer term expectations</p> <p>Partner with Procurement, Supplier Quality Engineering (Corp and PML), Sustaining Engineering and suppliers on both Supply and Quality issues. Ensure Designs, Manufacturing, Validation, and PM plans line up with our own internal requirements and regulations.</p> <ul> <li>Implement initiatives and cost savings as defined by the leadership </li><li>Be able to independently lead a team navigating through hurdles, achieve performance, consider input from multiple functional areas & address the problem through a holistic method </li><li>Assist business unit leadership in implementation of road maps for core processes and process controls. </li><li>Lead DFM/DFA, Mold Design, Process Development, PM plans, with R&D, Suppliers and Operations </li><li>Represent AME supporting Procurement, SE, Procurement Operations, on tooling, plastic, and process issues at suppliers and PML. Drive excellence in Design, Manufacturing, and Operations Processes Keep skills up to date through training, tech shows, tech sites/magazines, technology associated with Tooling, Molding, and Automation.( CAD, Mold Flow, Scan Analysis, Reverse Engineering, Statistical Tools, Molding Process) </li></ul> <p>Knowledge, Skills & Qualifications</p> <ul> <li>7+ or more years of Mold Tooling and or Plastics Processing Technology experience with 7 years of hands-on experience involving successful launches of plastic injection molded components for Mechanical assemblies. </li><li>Must have a successful track record of implementing new designs and/or design changes. This includes active participation in the entire process of design, test, manufacturing start-up, and launch of projects. </li><li>Has in-depth knowledge Quality Systems, DFA/DFM, MSD concepts, PFMEA knowledge. </li><li>Proficient in the use of CAD, MOLD FLOW, and Scientific Molding related to engineered plastic manufacturing. </li><li>Proficient in the use of basic office programs, such as Word, Excel, PowerPoint, Project, and Outlook. </li><li>Strong leader ship interpersonal and communication (verbal and written) skills. </li><li>Proven track record of excellence in leading program problem-solving and troubleshooting tooling and processing issues. </li><li>Outstanding attention to details, excellent organizational skills, with an ability to work in and lead complex cross functional teams. </li></ul> <p>Education and Experience</p> <ul> <li>Bachelor's Degree or Journeyman Mold Maker . </li><li>7+ years of extensive hands-on experience in plastics and tooling. </li><li>Well-rounded in Plastic Tooling, Plastic Processing, and Manufacturing Engineering </li><li>Plastics Injection Mold Design, Plastic Simulation, and Assembly Automation also a plus </li></ul> <p>Minimum Qualifications</p> <ul> <li>Must be at least 18 years of age </li></ul> <p>Travel Requirements</p> <ul> <li>Typically requires travel 20 to 50% of the time </li></ul> <p>Physical Requirements and Work Environment</p> <ul> <li>Work is performed in a clean room environment </li><li>While performing the duties of this job, the employee may be required to sit or stand for long periods of time </li><li>Employee is required to use computer or touch screen to enter work order data </li><li>Must be able to occasionally move and lift objects of up to 25 lbs. </li></ul> <p>ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.</p> <p>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.</p> <p>We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:</p> <ul> <li>Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. </li><li>The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. </li><li>IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. </li><li>Significant US IV solutions manufacturing and supply capabilities. </li></ul> <p>This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.</p> <p>ICU Medical EEO Statement:</p> <p>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.</p> <p>If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.</p> <p>ICU Medical EEO Policy Statement</p> <p>Know Your Rights: Workplace Discrimination is Illegal Poster</p> <p>ICU Medical CCPA Notice to Job Applicants</p>