Engineer I, Product Design

About the Role

The Product Design Engineer will support the Business Development R&D department, responsible for developing and implementing new products. This role focuses on designing, developing, and improving ICU's product portfolio for efficiency and reliability, with a heavy involvement in plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The engineer will interface with internal customers and external suppliers for high-volume disposable medical devices and assist with development and compliance challenges for new medical devices.

Key Responsibilities

• Assist in the development of products from concept to production.
• Develop product requirements according to customer and business needs, complying with international standards and regulations.
• Adhere to established design control processes and good engineering practices.
• Design and model components and devices using SolidWorks.
• Evaluate parts, products, or processes for efficiency and reliability.
• Provide technical support on components, material methods, systems, and equipment.
• Provide the technical foundation for the development of risk documentation.
• Develop test procedures to ensure specifications and regulations are met.
• Write, review, and approve protocols, reports, and data.
• Conduct testing outlined in protocols and test methods.
• Execute engineering and validation studies on products.
• Conduct failure investigations.
• Work on special projects as assigned.

Requirements & Tech Stack

• SolidWorks competency required.
• Understanding of engineering mechanics and physics.
• Familiarity with machine shop practices.
• Familiarity with drafting standards.

Qualifications

• Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field.
• 0-2 years of experience in Medical Device Product Development.
• 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, coaching, influencing, and team building.
• Knowledge of medical device manufacturing practices.
• Knowledge of medical grade plastics and general injection molding principles.
• Strong knowledge in joining methods of plastics.
• Experience with design of experiments (DOE) and basic statistical methods.
• Excellent project leadership and ability to expedite project completion.
• Master's Degree preferred.
• Must be at least 18 years of age.