The Staff R&D Engineer will be a key contributor in the design and development of disposable medical diagnostic devices. This candidate will have a proven track record of developing medical devices and bringing them to market. This candidate will excel in a dynamic and exciting workplace environment.
Design and develop parts and modules in the creation of novel diagnostic molecular test products.
Define design requirements, specifications, and drawings to ensure product function.
Transfer design to manufacturing and vendor selection to support high volume scale up.
Lead contributor during design development process, providing input to DHF, and leading informal and formal design reviews
Perform or supervise others to perform experiments to verify mechanical and/or assay performance.
Research through concept development, prototype, or analysis candidate designs or methods for future products.
Performing necessary analysis to ensure proper product function. FEA, Tol stacks, etc.
Contribute to grant writing activities
Write patent disclosures
Other duties as assigned.
Education and/or Experience
BS in Bioengineering or Mechanical Engineering. MS preferred.
Greater than 7 years of experience in the development of medical devices.
Expert mechanical designer using Solidworks. 3D and 2D. GD&T ASME Y 14.5M - 1994
Extensive experience in the design of precision injection molded components and elastomers for high volume and low cost production of medical devices
Experience with products that perform precise fluid handling.
Knowledge of design control process for the development of class 2 medical device.
Test method development and validation
Excellent communicator, verbal and written
Demonstrated ability to work effectively under pressure, while maintaining the highest ethical
Demonstrated ability to hold highest ethical standards, serving as a role model both within and outside of the company.
Long periods of sitting and typing at computer for design and documentation activities.
Periods of sitting, standing and using upper body doing work at a laboratory bench for inspection, assembly, and testing of prototypes.