Patrick Owens Email & Phone Number

Sunnyvale, Ca

Developing Structural Heart Devices and Delivery Systems- SolidWorks based catheter and device design- 30 years of experience designing, sourcing and building cutting edge cardiac and vascular devices.Program Management from Concept to 10,000 units / monthManufacturing line set up and supportQuality System Leadership, implementation and utilization

Northern California

- Medical Device Product Realization- Hands on implementation of FDA & ISO 13485 Systems- Start up boot strapping: Facilities, Mfg. lines, Qual Systems- Device design and prototyping for bench, preclinical & clinical- Member of 3 bay area Med Device Consulting Firms- Structural Heart, MICS, Cardiac Catheters / Interventional, Spine/Ortho, - Medical Device Design and Testing, Protocols and Reports- Design Control and Risk Analysis Systems and Reports- Packaging… Show more - Medical Device Product Realization- Hands on implementation of FDA & ISO 13485 Systems- Start up boot strapping: Facilities, Mfg. lines, Qual Systems- Device design and prototyping for bench, preclinical & clinical- Member of 3 bay area Med Device Consulting Firms- Structural Heart, MICS, Cardiac Catheters / Interventional, Spine/Ortho, - Medical Device Design and Testing, Protocols and Reports- Design Control and Risk Analysis Systems and Reports- Packaging and Sterile Barrier Design and Testing- Disposable and Reusable Sterile Challenge Testing and Reports. Show less

Campbell Ca

• Managed CTO and Thrombolytic catheter projects for clients. Responsible for client interface, project management. Worked on and supported Mitral Valve delivery systems and other company projects.• Managed day to day build and development activities. Builds utilized SS wire braiding, Vertical shrink laminations, FEP skiving, Tip forming, Glass mold sizing, NiTi forming/processing, and Laser welding. Worked with Techs and Operators to improve the consistency / predictability of build… Show more • Managed CTO and Thrombolytic catheter projects for clients. Responsible for client interface, project management. Worked on and supported Mitral Valve delivery systems and other company projects.• Managed day to day build and development activities. Builds utilized SS wire braiding, Vertical shrink laminations, FEP skiving, Tip forming, Glass mold sizing, NiTi forming/processing, and Laser welding. Worked with Techs and Operators to improve the consistency / predictability of build results. Trained new production personnel. Generated and updated device LHR’s, MPI’s and other required documentation and reports.• Worked with customers to improve product performance and address issues seen on the bench and in Pre and Clinical trials. Show less

Menlo Park, Ca

Virtual

Burlingame, Ca

Fremont, Ca

San Francisco, Ca

Hayward, Ca

Mt. View, Ca

Start up company developing a cardiac output catheter. Designed and implemented piezo transducer potting fixtures and processes