The Product Sustaining Engineer III is responsible for supporting product improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined procedures during project support & improvements.
The Product Sustaining Engineering III will complete advanced engineering projects with input and guidance from senior engineers and managers. Gains exposure to some of the complex tasks within the job function.
Essential Duties & Responsibilities
Support initiatives for continuous process and product improvements
Work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance's 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)
Identify and qualify "end-of-life" components.
Represent Sustaining Engineering to identify possible product modifications to improve manufacturability and impact on production processes.
Initiate and manage projects with adherence to program management guidelines
Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
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.
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 on special projects as they arise
Knowledge, Skills & Qualifications
Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
Knowledge of Solidworks to interpret part dimensions, sectional views, conduct mates, build assemblies.
Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations is a plus
Competent in your domain. Familiar with other areas of domain expertise within the team.
Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
Have awareness of the broader product strategy and contribute to it
Ability to receive general project direction and solicit input from more experienced engineers.
Requires the ability to independently make decisions that impact the attainment of project
Minimum Qualifications
Must be at least 18 years of age
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
4+ years of experience in Medical Device Product Development or related field
Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
Typically requires travel less than 5% of the time
About ICU Medical Inc.
ICU Medical, Inc. is a global medical device company that develops, manufactures, and sells innovative medical products used in vascular therapy, oncology, and critical care applications. The company's products are designed to improve patient outcomes by helping prevent bloodstream infections and protecting healthcare workers and patients from exposure to infectious diseases or hazardous drugs. ICU Medical's product portfolio includes needlefree connectors, closed system transfer devices, and other medical devices and accessories. The company has operations in North America, Europe, and Asia and employs over 5,100 people worldwide.
