Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak™ CTS is the only commercially available FDA cleared and CE marked transport device for heart transportation. Paragonix is also developing transport devices for the lung and kidneys designed to improve donor organ quality and extending donor organ transport time.
Reporting to the CTO this position will assist with guiding products from the design and concept stage to the manufacturing phase and ultimately, to commercial distribution.
Primary responsibilities will include:
· Research, development, and realization of novel product concepts in support of Paragonix pipeline
· Production of representative CAD modeling
· Transition new products from concept to manufacturable design in an FDA- and ISO 13485-compliant environment in conjunction with operations and quality teams
· Interface with and translate team marketing/sales/R&D concepts into design inputs, designs and prototype outputs
· Prototype generation and testing (design verification and design validation)
· First article inspection and evaluation for new product lines
· Employ SolidWorks software package and PDM Pro to migrate and organize pre-existing CAD library into new storage, in concert with Quality group, manage CAD drawings storage vault
· Assist quality, operations, engineering and other necessary functions to develop in-process and post process product function/quality checks
· Manage on-going product and process improvement through design and process modifications in response to end user-derived inputs and feedback
· Produce updates to product labeling in concert with quality and marketing
· Provide input in development of training materials in to clinical, sales, marketing, quality
· 7-13 years of manufacturing design engineering experience preferably within the medical device/technology industry.
· Demonstrated ability to facilitate advancement of a product through concept process to manufacture
· Bachelor’s degree in an applicable engineering discipline required.
· Advanced degree in an applicable engineering discipline preferred
· Experience in FDA- and ISO 13485-compliant environment desired.
· Proficiency in Solidworks and PDM Pro required
· Onsite personnel (post-pandemic)
· Must be willing to travel 5%-10%
To apply, send your resume and cover letter here.