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Golds Associates

 

Leading product development teams...

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  • Led a project a team of 6 engineers to efficiently create input phase documentation for two implantable vascular product projects for large medical device company division within schedule.   
  • Led a team composed of a mix of consultant and client engineers to generate missing vascular device design control elements for a manufacturer of invasive therapeutic products unable to adequately respond to an MDR reportable event. Provided resource plans, schedules and reports.  The resulting DHF enabled the company to adequately respond to FDA.
  • Led a team of designers and component suppliers to reduce cardiac implant IP to practice in just 4 months for a world famous university research hospital. Client successfully licensed IP.
  • Led a team of 4 consultant engineers to complete the concept phase of next generation cardiac device in 4 months for start-up. Consultant team worked through all phases from initial brainstorming, through design and prototyping to in-vivo testing, and documentation.  Also managed a novel implant project at the same client, created project strategies based on critical path analysis of prototype schedules which led upper management to realign project prioritities.




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