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Sr. Manager of R&D

Company: Kelly Science, Engineering, Technology & Telecom
Location: Torrance
Posted on: June 19, 2022

Job Description:

Sr. Manager of R&D - Direct HireKelly Engineering Resources is hiring a Sr. Manager of R&D for a premiere client in Torrance, CA. This is a Direct hire opportunity where you will be part of an advanced medical device company dedicated to the research, development and commercialization of a miniaturized implantable ventricular assist system featuring total magnetic suspension for the treatment of end-stage chronic heart failure. With offices in the US and China, we are growing our US team in preparation for clinical studies and regulatory approval in the US and EuropeWhat You Will Need for this Sr. Manager of R&D Position:

  • B.S. or higher degree in Biomedical Engineering or related field
  • 10+ years of experience as an R&D Manager
  • 10+ years of industrial experience in Class III medical device R&D, regulatory approval, and commercialization
  • MUST HAVE Ventricle Assist Device (VAD) experience
  • VAD experience is critical, class 3, project management, would be open to people who have worked with other heart devices if not VAD exp, exp with Management-they will manage a team of 6.
  • Extensive experience in project management and team management
  • Extensive experience in working with regulatory bodies, research institutes, CROs, clinicians, vendors, and outside consultants
  • Extensive experience in implantable medical device design, testing, manufacturing, documentation, and problem solving
  • Proficient in medical quality management systems 21 CFR Part 820 ISO 13485
  • Comprehensive familiarity with ISO 14708, IEC 60601 and other medical device standards
  • Excellent interpersonal and technical communication skills
  • Ability to work in a dynamic global environment with multiple changing priorities
  • -20% domestic and international travelAdditional to have:
    • Remote with some travel, if you are based in Southern CA or Florida, will look at candidates in Washington or Mid West, Travel at least once a month.
    • Don't need to be fully vaccinated
    • M-F, 1st shift, 8-5 or 9-6 occasionally evening calls with ChinaWhat you will be doing:
      • Lead US R&D team
      • Work with leadership on the company's new product strategy
      • Establish development plans for new products and line extensions
      • Ensure timely completion of new product development projects in compliance with regulatory
      • standards.
      • Support company AOP and budget
      • Provide training, coaching, and mentorship to team members
      • Support QMS and design controls including specification, risk analysis, design history files, etc.
      • Identify potential design issues and solutions in compliance with FDA, ISO and other
      • requirements
      • Interact with regulatory bodies and lead FDA applications
      • Interact with clinicians and CROs and lead U.S clinical trials
      • Support regulatory inspections/audits and timely resolution of CAPAs
      • Support smooth technology transfer and commercial scale-up
      • Execute the vision and strategy for the organization
      • Drive a culture of creativity and innovation#TJP2022_SPEC, #R&D, #researchanddevelopment, #manager, #VAD

Keywords: Kelly Science, Engineering, Technology & Telecom, Torrance , Sr. Manager of R&D, Executive , Torrance, California

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