Phil Ahrens

About Phil Ahrens

In my latest venture with ReValve Solutions I have enjoyed the rare opportunity to…

Experience

1. Principal Engineer - New Process Development

   Revalve Solutions

   Nov 2019 — Present · Bainbridge Island, WA, US

   As a member of the original ReValve team, I’ve been able to strengthen my skills in the start-up environment while developing the necessary procedural rigor required of a breakthrough technology company in the highly competitive and resource-intensive world of structural heart devices. Adopting the title of “Biomedical Director” early on, and adopting the start-up mantra of “Do whatever needs to be done, and do whatever it takes to get it done,” I played a primary role in identifying, securing, and building out our first facility; later expanding the facility to double the footprint and staff as our in-house requirements grew, and ultimately moving the company from the Seattle area to Southern California to be in the heart of the industry. As the first and second generations of the product emerged, I took on the role of leading the in-house testing of the Transcatheter Delivery System and continually evolving the simulated-use environment. I\'ve supported the path to clinical evaluation through protocol development, cleanroom setup and certification, device packaging and sterilization, and ultimately to scrubbed-in case support of successful OUS first-in-human clinical procedures. As our successes mounted, the demand grew for more specialized skill sets and to be more accessible to the elite clinical community. It became clear that relocating to Southern California was the logical choice. Having spearheaded that relocation effort, I am able to enjoy a more manageable workload as in-house expertise has been steadily vetted and brought on board. Clinical case support, logistics, and helping to implement a robust quality system are my primary missions as we plan Early Feasibility and Pivitol studies in the U.S. Now firmly established in So. California, we will continue to become a recognized treatment breakthrough within the Mitral Valve treatment space, with a core technology platform that will continue to shape structural heart treatment options into the future.

Education

• The University of Texas Southwestern Medical School

  Master of Science (MS)

• DeVry University

  Bachelor of Science (BS)

Skills

• R&D
• Product Development
• Medical Devices
• Electronics
• Testing
• Engineering
• Start-Ups
• Strategic Planning
• Strategy
• Electronics Manufacturing
• Electronics Hardware Design
• Biomedical Engineering
• Regulatory Affairs
• Intellectual Property Strategy
• Cross-Functional Team Leadership
• New Business Development
• Manufacturing
• Product Management
• Project Management
• Research and Development (R&D)
• Management
• Business Strategy
• Leadership
• Business Planning
• Entrepreneurship
• Market Development
• Biotechnology
• Engineering Management
• Program Management