Engineer III, Product

ICU Medical Inc; Salt Lake City (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

ICU Medical Inc. is seeking a Product Sustaining Engineer III to support product improvements under design control guidelines. The role emphasizes judgment and adherence to procedures across project support and enhancements.

The position focuses on sustaining engineering for medical devices, driving continuous improvements, partnering with manufacturing and quality teams, and delivering detailed specifications and training to staff.

Qualifications

• 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.
• Must be at least 18 years of age.

Responsibilities

• Support initiatives for continuous process and product improvements.
• Work to improve performance of manufacturing systems (yield, cycle-time, quality).
• Support project timelines and milestones and bring them to completion on time and within budget.
• Assist in completion of CAPA tasks and deliverables.
• 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.
• Conduct independent analysis and develop solutions to problems.
• Develop approaches and designs where precedent usually exists.
• Perform developmental and/or test work relying on theory and design knowledge.
• Write detailed design specifications.
• Assist in training new/current employees with respect to documentation, equipment, lab techniques and procedures.
• Deliver communications tailored to receivers (managers, peers, customers) to maximize utility and collaboration.
• Work on special projects as they arise.

Skills

Strength of materials

Automation

Plastic injection molding

Part assembly

Fixturing

Testing

Process control

SolidWorks

Six Sigma

Minitab

FDA QSR

Education

Bachelor's degree in Mechanical Engineering

Master's degree preferred

Tools

SolidWorks

Minitab

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.

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