Engineer I, Product Design

About the Role

The Product Design Engineer will support the Business Development R&D department. The engineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is to design, develop, and improve ICU’s product portfolio to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Product Engineer will be expected to interface mainly with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. The position requires the ability to interact with multiple functional groups such as Marketing, Regulatory, Quality, Operations, etc.

Key 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 regulations applicable.
• Adhere to established design control processes and good engineering practices
• Design and model components and devices for various product lines using SolidWorks
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines
• Provides technical support on components, material methods, systems and equipment
• Provides the technical foundation for the development of risk documentation
• Develops test procedures to ensure specifications and regulations are met
• Writes, reviews, and approves protocols, reports and data
• Conducts testing outlined in protocols and test methods
• Executes engineering and validation studies on products
• Conducts failure investigations
• Work on special projects as assigned

Requirements & Tech Stack

• SolidWorks competency required
• Familiarity with machine shop practices
• Familiarity of drafting standards

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.
• Detail oriented and ability to organize large amounts of work and data.
• Strong interpersonal skills required in the areas of 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
• Understanding of engineering mechanics and physics