Engineer I, Product Design

About the Role

The Engineer I, Product Design position in the Vascular Access Product Engineering team will manage product design changes for post-market products in the medical field. This role involves collaborating with Product Design Engineers, Systems Engineers, R&D Testing Labs, Marketing, Design Assurance, and internal and external Manufacturing teams. The primary focus is supporting post-market development and performing design verification of medical device components and products of varying complexity. The engineer is responsible for developing and implementing design and development plans through adherence to established design control processes and good engineering and documentation practices. Familiarity with Minitab and SolidWorks, or comparable statistics and CAD software, is a plus.

Responsibilities

• Organizes, plans, and executes formal design verification activities for small to medium-scale design change projects, and supports similar activities for other projects of varying scale.
• Writes test protocols, performs test method validations, executes test plans, and authors test reports with data analysis and technical conclusions.
• Supports risk management activities through hazard analysis and design failure and effects analysis (DFMEA), and identifies and implements risk mitigation.
• Supports the analysis and evaluation of solutions to complex problems.
• Conducts investigations of varying complexity pertaining to changes in designs, methods, materials, or processes, and investigates possible applications of the results.
• Assists in root cause analysis and the development and implementation of solutions for non-conforming events through the Corrective Actions and Preventable Actions (CAPA) process.
• Adheres to established design control processes and good engineering practices.
• Designs and models components, devices, test fixtures, prototype/pilot tooling for various product lines using SolidWorks.
• Develops test procedures to ensure specifications and regulations are met.
• Executes engineering and validation studies on products.
• Works on special projects as assigned.

Qualifications

• 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.
• Experience in Medical Device Product Development preferred.

Skills

• Detail-oriented with the ability to organize large amounts of work and data.
• Strong interpersonal skills in verbal and written communications, customer focus, time management, professionalism, and team building.
• Excellent project leadership and ability to expedite project completion.
• Able to review and interpret technical documentation such as engineering drawings and component specifications.
• SolidWorks competency preferred.
• Minitab or similar statistics competency preferred.
• Understanding of engineering mechanics and physics.
• Able to analyze technical problems, develop creative solutions, and implement effective changes.
• Familiarity with machine shop practices.
• Familiarity with drafting standards.

Work Environment

This is largely a sedentary role operating in a professional office environment and routinely using standard office equipment. Typically requires travel less than 5% of the time.

About Us

ICU Medical consistently provides 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. Our focus allows us to bring dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization, the industry’s broadest IV smart pump offering, IV medication safety software, and significant US IV solutions manufacturing and supply capabilities.