CareTaker Medical is seeking a self-motivated, energetic product manager with experience managing Class II Medical Devices through the full life-cycle of product definition, engineering development, clinical validation, regulatory approval, and product launch.  This position has full product ownership responsibility and is the chief interface between our development, sales, marketing, supply-chain, and clinical efforts.   This position reports directly to the CEO.  Key responsibiilties include:


  • Create and manage full life-cycle project plan & product roadmap
  • Lead the coordination and documentation of project team activities including kick-off meetings, design review meetings, V&V activities, Design History File, and clinical trails
  • Directly Manage key Supply Chain partners to insure seamless delivery & execution
  • Perform and maintain market analysis by product and channel segment to define next-gen product/features and identify new channels/markets
  • Develop technical guides, product literature, brochures, sales binders and all sales support information for BtoB Channel Partners
  • Manage FDA submissions and insure compliance with all relevant regulatory bodies
  • Plan, organize and execute courses and symposia for specific product introductions in conjunction with sales and clinical R&D
  • Manage global product launch into all channels and geographies
  • Represent the company’s interests to regulatory bodies, medical boards, clinical investigators, industry press, and marketing partners
  • Assist in channel partner strategy and business development 

This position receives early-stage equity ownership, a competitive salary, liberal benefits, and a family-friendly culture.

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Desired Skills and Experience

  • 3+ years experience successfully launching and managing FDA-Regulated electronic-based medical devices to market
  • Desire to work in a fast-paced, entrepreneurial environment
  • Experience with successful 510(k) and CE-Mark Medical Device Approvals
  • Exceptional project management skills and track record of success
  • Demonstrated experience in the following areas is a plus: Vital Sign Monitoring, Hemodynamic Monitoring, Wireless Medical Devices, EMR/HMR data integration.
  • Demonstrated understanding of medical device marketplace, channels, reimbursement models, and buying-decision criteria
  • Well organized, detail oriented, self-motivated and team player capable of working in a deadline driven environment
  • Ability to create and confidently deliver effective and persuasive presentations to multiple size audiences
  • Ability to travel up to 15-20% of the time