Quality Engineer I - Complaints (hybrid)

The Engineer I, Quality – Complaints will methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner. The Engineer I will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed. **Position Summary** The Engineer I, Quality – Complaints will methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner. The Engineer I will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed. **Essential Duties & Responsibilities** - Methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner - Identify critical dimensions on component drawings and submit dimensional inspection requests - Carry out basic standardized test methods and/or submit functional testing requests - Establish and maintain communication both internal and external (with the customers and regulatory personnel as needed) - Domestic and International Regulatory vigilance reporting is essential - Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements. - References existing work to complete similar projects. Improves on previous work. - Provides input to the product teams regarding the development of new designs, methods or processes. - Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision. - May assist in training new 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 on special projects as they arise **Knowledge & Skills** - A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting - Take in and communicate information effectively - Communicate externally as needed, and do so in a professional manner - Knowledge of Microsoft Word, Excel, and Outlook - Has engineering foundation. - Expected to spend majority of time learning and best practices. - Has a basic understanding engineering discipline. - Willingness to learn/understand big picture. - Ability to complete projects with minimum supervision. - Requires the ability to provide input and recommendations that impact the completion of project goals. **Minimum Qualifications, Education & Experience** - Must be at least 18 years of age - Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM) - 0-2 years experience - Prior experience in quality assurance is preferred. - Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required. **Work Environment** - This job operates in a professional office environment and routinely uses standard office equipment - Work is performed in a safe environment. - While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled laboratory setting - Must be able to occasionally move objects up to 15 lbs. ### About the Company 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 t…