Engineer III, Mechanical - HDM

ICU Medical•Salt Lake City, UT

2d•Hybrid

About The Position

The Engineer III, Mechanical will design and develop mechanical and electro-mechanical components for medical devices. This role is responsible for developing and implementing new products, changes to on-market products, and DHF support documentation through adherence to established design control processes and good engineering and documentation practices. The engineer will develop CAD models, theoretical models, perform engineering analysis, build prototypes, and conduct engineering studies to demonstrate design feasibility. Support for on-market and configuration management is also required, including assisting with Engineering Change Orders, Bill Of Materials, Process instructions, drawing updates, and document releases. The incumbent will interface mainly with internal customers and external suppliers on the design and configuration of electro-mechanical medical devices and interact with multiple functional groups such as Marketing, Regulatory, Quality, and Operations.

Requirements

Ability to triage a design concept and drive a solution to completion.
Familiarity with common engineering tools and processes such as geometric dimensioning and tolerance analysis (GD&T), tolerance stack-up analysis, and simulations utilizing Finite Element Analysis software tools such as ANSYS FEA or SolidWorks Simulation.
Knowledge of data analysis techniques using Minitab, Excel, and MATLAB.
Knowledge of medical device manufacturing practices.
Ability to identify technical risks and communicate the issue to project/engineering manager.
Ability to critically review and interpret technical documentation.
Intermediate to advanced problem solving and analytical ability.
Self-starter who can work independently to achieve project goals.
Ability to manage their own work load to achieve tasks assigned by management or more senior engineers.
Engineering degree from an accredited college or university is required.
Minimum 4 years of experience working in an engineering field.

Nice To Haves

Medical device or other regulated industry experience preferred.

Responsibilities

Assist in the development of products from concept to production.
Develop product requirements according to customer and business needs in compliance with international standards and applicable regulations.
Design and implement the mechanical aspects of electro-mechanical products including dedicated consumables.
Identify potential design issues and troubleshoot design problems as they arise.
Conduct engineering activities of intermediate to advanced scope or degree of difficulty, including designing and testing components, documenting findings, and communicating those findings to the broader team.
Develops test procedures and protocols to ensure specifications and regulations are met.
Execute engineering and validation studies on products.
Adhere to established design control processes and good engineering practices by following company Standard Operating Procedures and industry standards.
Work with vendors to facilitate the procurement of components needed for development.
Work with cross functional team members to meet overall project objectives.
Work on special projects as assigned.