Overview:



The R&D Engineer will support the Business Development R&D department. The R&D 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 CLIENT'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 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.



 



Roles & 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 assignments as they arise



Education & Experience:



Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.



0-2 years of experience in Medical Device Product Development and/or Manufacturing Support Engineering



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



SolidWorks competency required



Understanding of engineering mechanics and physics



Familiarity with machine shop practices



Familiarity of drafting standards