R&D Engineer II

Position Summary

This position is focused on product development stages including detailed design of new components and devices, creation of product specifications, identification of manufacturing processes, creation of equipment specifications, generating concept of operation for manufacturing equipment and is a contributor to the development of the product thru design verification, design validation and design transfer. 
The ideal candidate will be internally motivated and personally accountable to project success. They will also enjoy learning from and teaching others in the department to strengthen oneself and continue to improve the abilities of others on the team. 
It is expected that the candidate will be capable of generating fully defined 2D drawings for fabrication. The ability to work in a cross functional environment and gather needed information from other functions are critical skills to be successful in this position.
 

Principal Responsibilities

•    Generating detailed designs for surgical product concepts in an organized and consistent manner
•    Working with cross-functional project teams to execute development activities as projects advance through the product development process.
•    Developing 3D models and 2D drawings in SolidWorks for product designs, assembly fixtures, and auxiliary equipment leveraging design experience and department design standards and best practices. 
•    Developing product assembly documentation as required 
•    Support workstream leads and facilitate project success through project scoping, planning, team building and execution management activities.
•    Apply design for manufacturing principals to component and device design
•    Support operations and engineering by updating existing drawings as discrepancies are found, or as changes are made.
•    Initiate and own Engineering Change Notices (ECNs) for drawings and other controlled documentation.
 

Education / Experience Requirements

•    Bachelor’s degree in Engineering or related discipline required, Mechanical Engineer preferred
Minimum of five (5) years relevant engineering experience in a regulated industry required, medical device experience preferred, 1 + years of experience designing components within a medical device facility utilizing CAD software preferred
 

Specialized Skills / Other Requirements

•    Proficiency with Solidworks required.
•    Familiarity with various materials and processes, such as extrusion processing, injection molding, machining operations, fixture and tooling development, and adhesive and thermal bonding techniques
•    Experience and a working knowledge of quality systems and medical device regulations (ISO13485)
•    Working knowledge of ASME Y14.5-2009 Dimensioning and Tolerancing for Engineering Drawings standard including Geometric Tolerance and Dimensioning (GD&T)
•    Self-starter with strong proactive work ethic, well-organized and detail-oriented.
 

Working Conditions / Physical Demands

TRAVEL REQUIRED: 20 %

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