Josh E.

I have a comprehensive background in product development/project management within the confines of international medical device regulations. I thrive on taking vague ideas and ill-defined needs and turning them into concrete reality. I can start a medical device company from the ground up and I can do it on schedule. This includes...

From a Regulatory perspective:
--Initial regulatory requirements analysis for new markets (EU, Brazil, Australia, US, Canada, etc.)
--Identification of applicable test requirements (ISO standards, etc.) and management of test houses
--Interfacing with regulatory agencies (FDA Pre-subs) and writing of regulatory submissions such as FDA 510(k)s
--Quality System development and implementation to required standards (ISO 13485, FDA, MDSAP, etc.)
--Identification of loopholes and temporary workarounds to ease implementation pains and maintain profitability for small startup companies

From a Project perspective:
--Using good interpersonal skills to keep people motivated and excited
--"Conducting the orchestra", developing a logical rhythm of events and ensuring timely completion of tasks
--Turning "unknown unknowns" into "known unknowns", forseeing problems before they arise and altering the "orchestra" accordingly
--Coordination of teams on an international level
--Intelligently focusing energy on tasks with the highest variability, including procurement of additional expertise as necessary
--Always keeping an open dialog about the day-to-day changes in the "Good/Fast/Cheap, pick any two but only two of the three" trade-offs in milestone achievement

From a Product perspective:
--Development of design parameters from organization input (Sales, Marketing, Support, etc.)
--Nitty-gritty technical work like engineering drawings/drafting, statistical analysis, resdesigns due to manufacturing constraints, component supplier identification.
--Identification, qualification, and day-to-day management of international manufacturers
--Design History File/Technical File development and maintenance
--Design Transfer for complex electromechanical devices

From an Operations perspective:
--Part Number/Drawing Number/Revision Control development and implementation
--Engineering Change Order workflow and impacts
--Purchasing-Manufacturing-Sales-Shipment procedures and throughput
--ERP/MRP implementation including workarounds for system limitations