Ed Gillis
Sr. Vice President Devices at BioCardia, Inc.
- Role
- Sr Vice President Devices at Biocardia, Inc
- Location
- North Andover, MA, US
- LinkedIn followers
- 500 followers
About Ed Gillis
Entrepreneur and senior level executive with proven success in research and development and clinical manufacturing of products, early and mid-stage fundraising, early stage clinical trials. Provided leadership for and built from scratch R&D and product development teams, manufacturing groups and early stage companies. Extensive knowledge of product development and manufacturing in an FDA and CE compliant environment and early stage fundraising. Results-oriented expertise in technical team building, new product development, and clinical needs assessment. Specific expertise includes:• R&D pipeline strategic management • Intellectual property structuring • 34 issued US Patents, numerous worldwide patents and applications• Medical device/pharma/combination product manufacturing• Incorporating Physician and patient needs into product specifications• Design verification and validation• Developing and leading teams and individuals• Early stage US and OUS clinical studies• Early and Mid-Stage Fundraising• Regulatory compliance in product development and clinical manufacturing
Experience
Sr Vice President Devices
May 2020 — Present · San Carlos, CA, US
BioCardia, Inc, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company\'s approved products include the Helix™ transendocardial delivery system and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix System and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Education
University of Massachusetts Lowell
Bachelor of Science (B.S.), Biology
University of Massachusetts Lowell
Master of Science, Plastics Engineering
Skills
- Quality System
- V&V
- Patents
- Fda
- Engineering
- Manufacturing
- Product Development
- Medical Devices
- Start-Ups
- U.s. Food and Drug Administration (Fda)
- R&D
- Strategy
- Project Management
- Cross-Functional Team Leadership
- Commercialization
- Regulatory Affairs
- Product Design
- Product Launch
- Validation
- Softball
- Design Control
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.