Engineer III, Mechanical

ICU Medical; San Clemente (CA); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in IV therapy and critical care products seeks an Engineer III, Mechanical to design and develop innovative medical devices. The role involves working with cross-functional teams, ensuring compliance with standards, and executing engineering studies. This position is primarily remote, offering a dynamic work environment focused on quality and innovation.

Qualifications

• Minimum 4 years of engineering experience.
• Experience in medical device or regulated industries preferred.

Responsibilities

• Design and develop mechanical and electro-mechanical components.
• Collaborate with cross-functional teams to meet project goals.
• Conduct engineering activities including designing/testing components.

Skills

Problem Solving

Analytical Skills

Communication

Education

Engineering degree

Tools

ANSYS

SolidWorks Simulation

Minitab

Excel

MATLAB

Job description

Join to apply for the Engineer III, Mechanical role at ICU Medical

Position Summary

The Engineer III, Mechanical will design and develop mechanical and electro-mechanical components for medical devices. This role involves developing and implementing new products, making changes to on-market products, and supporting DHF documentation through adherence to established design control processes and good engineering practices. Responsibilities include developing CAD models, performing engineering analysis, building prototypes, and conducting engineering studies to demonstrate design feasibility. The engineer will also support on-market and configuration management activities such as Engineering Change Orders, Bill of Materials, process instructions, drawing updates, and document releases. The position requires interfacing mainly with internal customers and external suppliers on the design and configuration of electro-mechanical medical devices, and collaborating with multiple functional groups such as Marketing, Regulatory, Quality, and Operations.

• Assist in the development of products from concept to production
• Develop product requirements in compliance with customer needs, international standards, and regulations
• Design and implement the mechanical aspects of electro-mechanical products, including consumables
• Identify potential design issues and troubleshoot as needed
• Conduct engineering activities of intermediate to advanced scope, including designing/testing components, documenting findings, and communicating results
• Follow established design control processes and good engineering practices
• Work with vendors for procurement of components
• Collaborate with cross-functional teams to meet project goals
• Participate in special projects as assigned
• Develop test procedures and protocols to meet specifications and regulations
• Execute engineering and validation studies on products

Knowledge & Skills

• Ability to drive a design concept to completion
• Proficiency with engineering tools such as GD&T, tolerance stack-up analysis, and FEA software like ANSYS or SolidWorks Simulation
• Knowledge of data analysis tools such as Minitab, Excel, and MATLAB
• Ability to identify technical risks and communicate effectively
• Skill in reviewing and interpreting technical documentation
• Strong problem-solving and analytical skills
• Self-motivated with the ability to work independently
• Ability to manage workload to meet deadlines
• Knowledge of medical device manufacturing practices

Minimum Qualifications

• Engineering degree from an accredited institution
• Minimum 4 years of engineering experience
• Experience in medical device or regulated industries preferred

Work Environment

• Largely sedentary role
• Work in an office and engineering lab environment
• Travel 5-10% of the time

About Us

ICU Medical provides clinical innovations to address real-world challenges. With acquisitions in 2017 and 2022, we are a global leader in IV therapy and critical care products. We focus on quality, innovation, and value, offering a broad range of solutions including IV sets, smart pumps, and IV medication safety software. This role is remote, excluding residents of Colorado, California, Connecticut, Montana, Maine, or New York.

Equal Opportunity Employment

ICU Medical is committed to an inclusive workplace and is an Equal Opportunity Employer. We provide reasonable accommodations for individuals with disabilities during the application process.