Engineer I, Quality

Engineer I, Quality ICU Medical, Inc. - 3.1 Salt Lake City, UT Job Details Full-time 4 hours ago Qualifications Customer communication Project development phase management Project engineering Content creation for technical audiences Quality control statistical data analysis Preventive action implementation Statistical Process Control Technical writing within manufacturing Six Sigma methodology implementation Engineering process optimization Employee relationship building Good documentation practices (GDP) Corrective and preventive actions (CAPA) Mid-level GD&T Laboratory staff training Schedule management Collaboration with product development teams Bachelor's degree in engineering Vendor performance evaluation Production validation processes Quality control documentation Quality assurance standard operating procedures Laboratory techniques Vendor quality assurance Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Managing projects Technical training Full Job Description Position Summary Engineer I, Quality will support the ICU Quality Engineering Department and report to the Quality Engineering Manager. They are responsible for sustaining manufacturing and validations through adherence to established design control processes, good quality and documentation practices. The key responsibility of this position is to exercise judgement and act while adhering to defined quality procedures during project support & improvement. Engineer I, Quality 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. This position is 100% onsite at our Salt Lake City, UT manufacturing facility. Essential Duties & Responsibilities Immediate Responsibilities Support initiatives for continuous quality improvements. Under the guidance of the Quality leadership, work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance needs. 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) Quality technical expert for a manufacturing production line Create and edit documents to support Quality. Reference 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. Long-term responsibilities Initiate and manage projects with adherence to program-management guidelines. Participate in vendor assessment and review of materials/machine technical information. Build productive relationships internally and externally. Work with Product, Manufacturing, and Molding Engineers on qualification activities for new or modified processes and equipment. 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 Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) Technical writing competency Has engineering foundation. Expected to spend majority of time learning and best practices. Has a basic understanding of 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. Knowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts (desirable) Minimum Qualifications, Education & Experience Bachelor's degree from an accredited college or university (Engineering, Technology, or STEM) 0-2 years' experience (Medical Device or Engineering) Must be 18 years of age Work Environment This is largely a sedentary role. Typically requires travel less than 5% of the time. This job operates in a professional office environment and routinely uses standard office equipment. Must be able to occasionally move and lift objects of up to 25 pounds. Work is partly performed in a clean room environment