Sascha Zarins
Summary
Looking for a clinical specialist position. Having worked in the industry as an engineer and working with engineers in the company and physician is a specialty. Also would love to do hands on case support and monitoring with clinical research staff at the various clinical sites.
I stepped away from the medical device industry to pursue designing and flipping house in Los Gatos and Saratoga full time in 2011. I am ready to return to full time medical device work.
Overview
30
30
years of professional experience
1
1
Language
Work History
Owner
Zarins Home Renovation, Inc.
01.2011 - Current
- Acquisition, design, project managing, permitting, performing various trades and sale to upgrade 6 homes in the Los Gatos – Saratoga area of California
Clinical Specialist
RenovoRx Inc.
01.2017 - 12.2020
- Involved with physician and site training for an FDA study treating pancreatic cancer with local intra-arterial chemotherapy
Clinical Manager
The Foundry, Vision 2
01.2008 - 01.2011
- In charge of a large clinical study (over 30 clinical sites) for a novel treatment of glaucoma with the use of a punctal plug drug delivery system
- Identified sites, completed IRB approvals, site initiations, monitoring and electronic data capture systems at all sites
- Also managed a team of clinical specialists to assist in all tasks at the many sites
- Acquired by QLT, Inc
Clinical Manager
FlowCardia Inc.
01.2005 - 01.2008
- Completed all of the same duties below as well as managing, training and mentoring other clinical specialists in their clinical study duties
- Acquired by CR Bard, Inc
Clinical Specialist
FlowCardia Inc.
01.2003 - 01.2005
- Assisted the regulatory department in writing and implementing a new clinical protocol for FDA submission, as well as all the accompanied documentation for a device designed for treatment of Coronary and Peripheral Chronic Total Occlusions (CTO’s)
- Spearheaded recruiting, training, monitoring clinical sites throughout the study
Engineer to Senior Engineer
Vivant
01.2001 - 01.2002
- Lead engineer in the design of a radiopaque marker and delivery system for marking the location after a breast biopsy has been performed
- Instrumental in a novel delivery method and type of marker used in the procedure
- Trained physicians in the use of the novel device
- Also designed many working prototypes for novel related medical devices
- Acquired by Tyco, Inc
Engineer
TransVascular, Inc.
01.1999 - 01.2001
- Lead engineer on manufacturing (later automated manufacturing), testing and supplying a support catheter (multiple sizes) for use with the TransVascular Pioneer catheter
- Assisted in many animal studies to test the use of multiple catheters in this complex procedure for heart bypass surgery
- Also designed many working prototypes for novel related medical devices
- Acquired by Medtronic
Engineer 1 to Engineer 2
AneuRx. Inc.
01.1997 - 01.1999
- Assisted in design of the Thoracic Aneurysm Stent-Graft
- In charge of writing and implementing test protocols, manufacturing and completing testing for FDA submission for the Thoracic Aneurysm Stent-Graft
- Assisted the clinical department by attending and assisting clinical investigators in the use of the Stent-Graft System during FDA cases, including training of staff and clinical investigators
- Also designed many working prototypes for novel related medical devices
- Acquired by Medtronic
Associate Engineer
AneuRx. Inc.
01.1996 - 01.1997
- Wrote test protocols and designed new versions of test equipment to complete testing for FDA submission for the AAA stent-graft
- Attended and assisted the clinical department with technical training on the delivery catheter, handle and use of the AAA stent-graft in the FDA clinical study at multiple clinical sites
- Also designed many working prototypes for novel related medical devices
Test Technician
AneuRx. Inc.
01.1995 - 01.1996
- Conducted all stent-graft testing on all components of the AneuRx Abdominal Aortic Aneurysm Stent-Graft, delivery system and handle
Education
Bachelor - Molecular, Cellular and Development Biology
University of Colorado At Boulder
Skills
Microsoft Office
3-D modeling
undefinedAccomplishments
Holder of five US Patents associated with medical devices
Timeline
Clinical Specialist
RenovoRx Inc.
01.2017 - 12.2020
Owner
Zarins Home Renovation, Inc.
01.2011 - Current
Clinical Manager
The Foundry, Vision 2
01.2008 - 01.2011
Clinical Manager
FlowCardia Inc.
01.2005 - 01.2008
Clinical Specialist
FlowCardia Inc.
01.2003 - 01.2005
Engineer to Senior Engineer
Vivant
01.2001 - 01.2002
Engineer
TransVascular, Inc.
01.1999 - 01.2001
Engineer 1 to Engineer 2
AneuRx. Inc.
01.1997 - 01.1999
Associate Engineer
AneuRx. Inc.
01.1996 - 01.1997
Test Technician
AneuRx. Inc.
01.1995 - 01.1996
Bachelor - Molecular, Cellular and Development Biology
University of Colorado At Boulder
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