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R&D Product Engineer

Location:Morrisville, NC
Salary Range:Dependent Upon Experience
Benefits:Comprehensive Benefits Package including 401(k)
Employment Type:Full Time
Description:This is a Product Engineering role responsible for troubleshooting and solving mechanical component and sub-system challenges that arise during the lifecycle of multiple product lines in a medical device environment. Requires the ability to identify an issue, determine root cause, recommend options for resolution, and implement the corrective action in a timely manner. A successful candidate will have experience in the design, development and sustaining of mechanical systems in a manufacturing environment, as well as solid communication and prioritization skills. The Product Engineer is responsible for providing engineering support to other functional areas within the company, and at times provides support directly to customers. The duties encompass supporting manufacturing to resolve issues associated with end-of-life components, supporting the Test Department on certain issues, supporting the quality department as needed, and occasionally providing recommendations for product improvements. This role is cross functional and will require interfacing with all functional groups.
Duties:Provide Technical / Production Support. This includes the following:
Acquire product and design knowledge that will be necessary to resolve issues, and support necessary design changes for multiple product lines.
Understanding the manufacturing processes to support in resolving continuity of supply issues with the product line.
Understanding of FDA guidelines and regulations related to medical devices.
Understanding GD&T practices and other applicable guidelines.
Visit OEM customer sites to both represent current product as well as work with defining their new product requests.
Provide Test/Project Support. This includes the following:
Provide assistance to the design and development team on assigned projects with interpretation and clarification of the application where required or requested.
Support the product line in the field including customer complaint and issue investigation.
Work with the R&D team to insure product requirements are identified and adequate test procedures are developed.

All Other Essential Duties as directed

Working within the project team to coordinate product sustainability and root cause activities utilizing the expertise of manufacturing, quality, regulatory, model shop, and other engineering support staff as necessary.
Qualifications:Education: BS in an engineering science applicable to the job description.

Experience: Minimum of 5 years of engineering experience required. Minimum level of application experience within the medical industry is three (3) years. History of working with the following technologies desired:
Medical disposable or re-useable devices
Cable driven mechanical systems
Electrosurgical Devices
Robotic systems

Demonstrated ability to identify issues, determine root cause, recommend options for resolution, and implement the corrective action in a timely manner.
Demonstrated knowledge of FDA guidelines as related to medical devices as well as understanding of ISO standards and GD&T practices.
Experience with Injection molding (plastic and metal), Extruding, and Machining.
Experience in Solidworks or similar CAD/CAM program desired.

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