Scientist Resume Salt Lake City, UT - Hire IT People

Profile

I haveover 10 years of experience in the medical device and biotech industry with a primary focus on research and development and product development of medical devices, biological therapeutics and molecular diagnostic equipment. My work experience is very diverse, reflecting my ability to rapidly acquire new skills in disparate fields of expertise. Most of my work experience has involved working for small start up businesses that require a high degree of self-motivation and unique problem-solving skills in a dynamic and demanding environment.

Experience

Sr. R&D Tech, Confidential, Salt Lake City, UT — 2008-present

This device relies on an extremely novel approach to harvesting autologous platelets and fibrinogen to be used primarily for orthopedic and cardio-thoracic surgery to promote wound healing and provide hemostasis. Provided key support in the primary design and development of a novel device for harvesting autologous platelets and fibrinogen from blood. The primary market is for orthopedic and cardio-thoracic surgery to promote wound healing and provide hemostasis included. Key responsibilities include; establishing design freeze, conduct design verification testing, contributing to risk management documentation (ISO 14971), conducting biocompatability testing (ISO 10993) and supporting preparing regulatory filings for the FDA and the European Union. I also provided key support for obtaining ISO 13485 Quality Management System certification for the company.

Sr. R&D Tech, Confidential — 2004-2008

I was responsible for supporting all key aspects of design and development of a novel guide wire technology. This includes; evaluating design inputs, developing product specifications, assessing and managing risk, FMEA, extensive bench testing such and cadaver testing of prototype devices, process development, design reviews and final design freeze, design verification and transfer to production. In addition, I have experience in process improvement (using DoE and process capability studies) and product design to meet 6-sigma standards.

Scientist, Confidential — 1999-2002

DNA based in vitro diagnostic device development: Key responsibilities included establishing market specification, biochemical assay development for real-time PCR diagnostics, SNP genotyping assay development, and project development.

Research, Confidential — 1993-1998

Studied the molecular processes of chromosome break repair by de novo telomere synthesis, and the role of chromosome breakage in developmentally programmed gene amplification.

Skills

Product development: Working familiarity with all principles governing design and development of regulated devices, such as Design Control, Design Verification, and Risk Management.
Engineering: FMEA, stress-strain properties of Nitinol alloys, design of experiment DoD, process capability and Solidworks.
Regulatory: Experience in FDA and CE Mark regulatory requirements.
Quality: Experience drafting and implementing Quality Management Systems for medical device manufacturers and GLP laboratories, and supporting quality system audits.
Manufacturing: Experience with process development and validation. Experience optimizing processes using Design of Experiments principles and reducing product defects using six sigma principles and statistical process controls.
Writing: Grant writing, regulatory submissions, marketing specifications, technical reports, test methods and protocols, manufacturing instructions.
Technical: Proficiency with manual and CNC machining of standard and exotic materials (e.g., Nitinol, inconnel, composites) and micro-scale machining. Proficiency with tool making, welding and brazing.

Education

BS Biology

Patents

Quantitative multiplex PCR with high dynamic range. U.S. Patent # 7118867.
Tabiti, Karim (US),Betzl, Gisela (Andechs, DE),Soong, Richie (Parap, AU),Rasmussen, Randy P (Salt Lake City, UT), Desilva, Deepika Marine (Salt Lake City, UT), Millward, Haleigh Page (Riverton, UT).

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Scientist Resume

Salt Lake City, UT

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