Engineer III, Mechanical at ICU Medical, Inc. in San Clemente, California

Job Description:

Position Summary


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



Essential Duties & 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. This could include 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.
• Executes 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.



Knowledge & Skills


• Ability to triage a design concept and drive a solution to completion

• Familiar 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.



Minimum Qualifications, Education & Experience


• Engineering degree from an accredited college or university is required.

• Minimum 4 years of experience working in an engineering field.

• Medical device or other regulated industry experience preferred.



Work Environment


• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Work in an engineering lab with test equipment is required.

• Typically requires travel 5-10% of the time.


Salary Range: $88,000 - $120,000

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.


ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Apply Now