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Josh Ellis | Elance
 
176985602337900
Last Sign-in: Mar 10, 2017

Josh Ellis

Senior Project Manager/Product Developer
   United States
  |   Boulder, UT
  |  7:36 am Local Time

Overview

Minimum Hourly Rate $150

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.

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Oct 5, 2015|Product Design|$2,330|Working
Oct 5, 2015|Product Design|$2,959|Completed
|
5.0
Mar 27, 2014|Other - Engineering & Manufacturing|$3,836|Completed
Nov 18, 2013|Other - Engineering & Manufacturing|$4,236|Completed
|
4.4

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Portfolio

Recreate a small circuit board and battery from physical sample, then design an enclosure.
Complete design from "napkin concepts" thru transfer-to-production including...
http://www.egi.com
Complete design from "napkin concepts" thru transfer-to-production including...
http://www.egi.com
Mechanical design services as part of a team to create a new 15' wide version of a...
Mechanical design services as part of a team to create a new 15' wide version of a...
Technical drawing for large, aesthetic front-bezel molded part. I designed the...
http://www.egi.com
I managed all the testing to bring a 100% cotton tampon to market and solely wrote the...
Rotationally molded airport barricade from concept to production.
Lead Engineer on the design and development of this EEG sensor net, featured on the...
http://www.egi.com

Skills (6)

Tested
Regulatory Affairs
Quality Systems

Service Description

From a Regulatory perspective:
--Initial regulatory requirements analysis for new markets (EU, Brazil, Australia, US, Canada, etc.)
--Identification of applicable test protocols (ISO standards, etc.) and management of test houses
--Interfacing with regulatory agencies and identifying consultants
--Writing of regulatory submissions such as FDA 510(k)s
--Quality System development and implementation to required standards (ISO 13485, FDA, CMDCAS, etc.)
--Identification of loop holes and temporary workarounds to ease implementation pains and maintain profitability

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...

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Employment

Naturalena Brands, Inc.
Director of Product Development & RA/QA
2011 - 2013
Founding member of an international natural products company focusing initially on feminine hygiene products. Manage all day-to-day product development activities and documentation including...
Electrical Geodesics, Inc.
Lead Product Engineer
2004 - 2008
Lead engineer for the Geodesic Sensor Net (GSN), a human/computer interface for brainwave measurement, and lead manufacturing engineer for the Net Amps 300 (NA300), an electronic amplification...

Education

Oregon State University
B.S. Bioengineering & B.S. Philosophy
1998 - 2004
Overview  |  Job History  |  Portfolio  |  Resume/C.V.

Keywords

Medical Device
FDA
Project Management
Product Development
Regulatory
Quality
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Josh Ellis | Elance

Josh Ellis