Engineer III, Product
ICU Medical
Summary
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.
Job description
Position Summary
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, 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
Requirements
- Must be at least 18 years of age
- Bachelor of Science degree in Mechanical Engineering or a related field
- 4+ years of experience in Medical Device Product Development or related field
- 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
- 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
Company overview
ICU Medical is a global medical device company specializing in infusion therapy, critical care, and oncology applications. Founded in 1984 and headquartered in San Clemente, California, the company develops, manufactures, and sells innovative medical devices used in hospitals and alternate care settings worldwide. ICU Medical's product portfolio includes infusion pumps, IV sets, closed systems for hazardous drug preparation, needle-free connectors, and critical care monitoring devices. The company is particularly known for its expertise in infusion therapy safety, having pioneered technologies that reduce medication errors and prevent bloodstream infections. With a strong focus on patient safety and clinical outcomes, ICU Medical serves healthcare providers across more than 90 countries. The company has grown through strategic acquisitions, including the purchase of Pfizer's Hospira infusion therapy business, which significantly expanded its global footprint and product offerings. ICU Medical maintains a commitment to quality, innovation, and improving patient care through advanced medical technology solutions.