Senior R&D Engineer

Position Summary

The Sr. Research and Development Engineer position is a combination of a technical leadership and individual contributor role. The position plays a critical role in conceiving and developing innovative products and advancing them through the product lifecycle. This position is focused on development activities, including solid modeling, drawing generation (SolidWorks), engineering analyses, test planning, test development, and execution. Some projects include the development of manufacturing and assembly equipment and fixtures allowing this position to be exposed to many different facets of engineering. The position will also participate in some  early development stages including problem identification, collecting input from end users, early concept development and proof of concept work (engineering studies). As a technical leader, the Sr. R&D engineer will work with project management to appropriately plan, de-risk, and execute projects. 

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. 
 

Principal Responsibilities

•    Leading product development projects from concept to commercialization and manufacturing transfer
•    Working with cross-functional core project teams to facilitate 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. 
•    Constructing of proof-of-concept prototypes to prove performance and de-risk future project activities
•    Developing product assembly documentation as required 
•    Building finished devices for design development and verification as part of the development process
•    Interfacing with physicians and other medical personnel in a professional manner, maintaining confidentiality and intellectual property vigilance
•    Generating new surgical product designs and concepts in an organized and consistent manner
•    Mentor peers and junior engineers and contribute to the culture of growth and development
•    Support project managers and facilitate project success through project scoping, planning, team building and execution management activities.
 

Education / Experience Requirements

•    Bachelor’s degree in Engineering or related discipline required
•    Bachelor’s degree in Mechanical Engineer preferred
•    Minimum of five (5) years relevant engineering experience in a regulated industry required
•    Proficient in SolidWorks, Microsoft Office (Word, PowerPoint, Excel, Outlook, etc.)
 

Specialized Skills / Other Requirements

•    Substantial experience taking products through the development process, successful regulatory approval, and launch
•    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 in project management, documentation, and a working knowledge of quality systems and medical device regulations (ISO13485)
•    Working knowledge and application of ASME Y14.5-2009 Dimensioning and Tolerancing for Engineering Drawings standard including Geometric Tolerance and Dimensioning (GD&T)
•    Ability to work independently, yet quickly and clearly communicate issues, risks, and risk mitigation plans to project team
•    Self-starter with strong proactive work ethic, well-organized and detail oriented
 

#LI-DR1