Greg Fung

Greg Fung Email and Phone Number

Design Control | Project Management | Product Pipeline Management | Intellectual Property Management | Technical Development | Feasibility Studies | Quality Systems Integration | Regulatory Submissions @ Eclipse Regenesis
Greg Fung's Location
Redwood City, California, United States, United States
About Greg Fung

Results oriented, accomplished, and innovative Research and Development Leader with 25+ years of experience in planning, developing, and implementing strategies for the development of medical devices in the cardiovascular, electrophysiology, structural heart, and cardiac surgical fields. Possesses a proven track record of building, leading, developing, and mentoring technical development teams, managing cross-functional resources, and projects while leading successful 510(k), PMA, IDE, and EUMDR submissions.Expertise in designing and developing creative solutions to complex problems for innovative products for use in subxiphoid, transceptal, femoral, and open surgical access procedures with extensive pre-clinical, clinical experience. Proven leadership in medical device research and development under Quality Systems that comply with ISO13485, MDR, and FDA Quality System Regulations.Possesses excellent project prioritization, pipeline development, and management skills, with extensive intellectual property portfolio management experience. Adept at handling multiple projects and tight deadlines in a fast-paced environment.Demonstrated ability to work as part of a team and manage initiatives that require collaboration across multiple functional areas.

Greg Fung's Current Company Details
Eclipse Regenesis

Eclipse Regenesis

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Design Control | Project Management | Product Pipeline Management | Intellectual Property Management | Technical Development | Feasibility Studies | Quality Systems Integration | Regulatory Submissions
Greg Fung Work Experience Details
  • Eclipse Regenesis
    Research Development Consultant
    Eclipse Regenesis Aug 2023 - Present
    Menlo Park, California, Us
    -Identified and modified existing stapling technology for concept evaluation in animal model-Researched existing endoscopic technologies (suture, staples, clips, clamps, etc) for ways to incorporate into new device design to treat Short Bowel Syndrome-Create agenda and lead User Needs discussion with group of physician advisors for next generation device-Attended new physician training animal lab for XL1 Tissue Regeneration Therapy Device-Initiated new device development into internal Design Control system
  • Atricure, Inc.
    Director Of Research Development
    Atricure, Inc. Aug 2019 - Mar 2023
    Mason, Ohio, Us
    -Developed and managed project budgets, departmental budgets, and quarterly spending strategies to maximize results while managing financial constraints.-Led engineering teams including external engineering partners for a steerable introducer device with integrated endoscope-Integrated SentreHeart Design History Files into Atricure Design Control System for 7 devices-Led product requirement integration with over 80 functional performance requirements, test development of over 30 tests, and testing completion on 7 devices for PMA and EUMDR submissions-Managed project and led technical development for steerable introducer device with integrated endoscoping imaging capability for subxiphoid over the wire pericardial access through project definition, concept, and feasibility phases-Implemented EUMDR compliant Implant Card for company's implantable devices
  • Sentreheart
    Vp Of R&D
    Sentreheart Jun 2007 - Aug 2019
    -Participated in executive planning sessions to develop and implement development strategies to meet corporate goals-Managed and prioritized device improvement and new product pipeline for future development resulting in constant device improvement-Participated in the ongoing evaluation of potential markets, new products, and new business opportunities-Planned, scheduled, and completed projects from concept through regulatory approval and commercial use in an aggressive manner consistent with corporate objectives -Collaborated with cross functional teams to determine new product development strategy from product inception to market launch-Recruited, hired, managed, mentored, and developed research and development staff members-Contributed to the overall intellectual property position of the company by aggressively encouraging and managing invention and patent applications and managing overall intellectual property portfolio-Worked closely with Interventional Cardiologist and Electrophysiologist key opinion leaders and clinical engineers to develop percutaneous LAA ligation system and procedure-Proactively supported company goals and objectives, policies and procedures, the Quality System Regulation, ISO/MDD regulations, and other regulatory requirements-Provided support in the resolution of product complaints-Provided engineering design and testing support or 510(k), CE, and aMAZE IDE Regulatory Submissions-Participated in pre-clinical feasibility studies and GLP Animal Studies to develop the clinical procedure and evaluate designs-Attended US and OUS clinical cases to develop relationships with industry-leading cardiologists and electrophysiologists-Supported First in Man studies for new product releases
  • Foxhollow Technologies
    Sr R&D Engineer
    Foxhollow Technologies Mar 2005 - Jun 2007
    Us
  • Guidant Corporation
    R&D Engineer
    Guidant Corporation Aug 1998 - Feb 2005
    Marlborough, Ma, Us
  • Guidant Corporation
    Research And Development Engineer
    Guidant Corporation Aug 1998 - Feb 2005
    Marlborough, Ma, Us

Greg Fung Education Details

  • University Of California, Davis
    University Of California, Davis
    Biological Systems Engineering
  • Santa Clara University
    Santa Clara University
    Engineering Management

Frequently Asked Questions about Greg Fung

What company does Greg Fung work for?

Greg Fung works for Eclipse Regenesis

What is Greg Fung's role at the current company?

Greg Fung's current role is Design Control | Project Management | Product Pipeline Management | Intellectual Property Management | Technical Development | Feasibility Studies | Quality Systems Integration | Regulatory Submissions.

What schools did Greg Fung attend?

Greg Fung attended University Of California, Davis, Santa Clara University.

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