<p>Quality Engineer II, Complaints - Salt Lake City, UT</p> <p>Responsibilities</p> <p>Be a product expert encompassing how the product was designed, how it is manufactured, associated failure modes, and how the product is used in the field. Must have the ability to methodically process and investigate medical device customer complaints in a high paced, efficient and accurate manner. Write effective investigation reports ensuring completion in a timely manner. Provide quality support and cross functional communication of customer experiences and complaint findings with the manufacturing sites. Liaison with quality, engineering, and operations and manufacturing locations to understand ongoing CAPA investigations and product issues. Contacting us customers to address ongoing issues, proactively identify potential issues, and provide updates/summaries for ongoing quality initiatives impacting the customer. Analyze weekly and monthly trend data according to procedure to identify if there is a bias or a trend does exist. Working effectively in a team environment with shifting priorities and time sensitive requirements. Must be capable of carrying out basic standardized test methods and/or submit functional testing requests. A willingness and capability to work with used, and therefore contaminated medical devices in a controlled setting. Performs other functions as necessary or as assigned. Work on special projects as they arise. 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. Writes detailed design specifications. Receives general project direction. Solicits input from more experienced engineers. 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 recipient (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross functional collaboration. Work on special projects as they arise. <em>Hybrid work is permitted. When not working from home, must report to Salt Lake City, UT office. </em>< 5% domestic and international travel required.</p> <p>EDUCATION AND EXPERIENCE REQUIREMENTS:</p> <p>Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, or closely related field (or foreign equivalent) plus Two (2) years of experience in the job offered or a closely related occupation.</p> <p>SPECIAL REQUIREMENTS:</p> <p>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: Experience working in a team environment successfully bringing medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS); Experience writing requirements and specification for regulated products/applications, including design traceability and verification and validation plans; Interpret drawings using GD&T measuring dimensions with equipment such as pin gages, calipers, rulers and performing torque tests, pull tests, etc.; Knowledge of Plastic Processing and disposable Medical Device manufacturing; Ability to handle safely and competently returned contaminated medical devices; Specialized knowledge of the manufacturing process and potential failure modes of infusion system consumable medical devices, such as: IV Admin sets, needless access devices, oncology closed system transfer devices, dedicated pump sets, dialysis sets, and monitoring kits; Experience with Medical Device Quality systems, corrective and preventive actions (CAPAs), non-conforming products (NCRs) and supplier corrective action reports (SCARs); Experience of failure mode analysis (5-Whys and Fishbone) and determining</p> <p>the probable root cause of the failures; Experience analyzing weekly data trends, identifying, and preventing potential market risks.</p> <p>ICU Medical, Inc. is an equal opportunity employer.</p> <p>To apply for ICU Medical's Quality Engineer II, Complaints position please send resume to: humanresouces@icumed.com</p> <p>Must reference JOB CODE: UT0515M</p>