Posting my Resume - Sr. Scientist seeking medical decvice R&D position

Brian Pikkula, Ph.D.
pikkula@gmail.com

I am currently searching nationwide for a Sr Scientist or preferably a Project Leader position in the medical device field. If you have a need for my qualifications, please do not hesitate to contact me.

Summary

Results-oriented Senior Engineer/Senior Scientist with more than 10 years of hands on experience in engineering, biomedical and optical technologies in academia, clinical trials, and medical device industry. Self-motivated with ability to handle several projects while managing others in an R&D setting. Proven track record of meeting deadlines and budget. Well developed communication skills. Principal author in 8 peer reviewed manuscripts, with16 total. Hands-on experience in:

· Development of FDA approved Class II device
· Manufacturing Process Development
· Root Cause Analysis, CAPA
· Verification and Validation
· Analytical and numerical modeling
· Fluorescence & Reflectance Spectroscopy
· Managing technical teams
· Clinical data acquisition & statistical analysis
· Liaison between engineers and physicians
· ISO 13485 and cGMP regulations
· FMEA/FMECA
· Study Design, DOE
· FDA submissions, NSR & 510k

Professional Experience

Remicalm LLC, Houston, TX 10/2007 – 11/2009
Sr. Research Scientist

· Scientific Lead on project redesigning portable cancer screening device that reduced failure rate by more than an order of magnitude. Developed models to enhance vascular contrast with limited available excitation spectra.

· Scientific/Engineering Lead developing an existing prototype spectrometer into a cervical cancer diagnostic device that was prepared for Phase III Clinical Trials. Improved SNR of spectrometer by more than 15x and increased dynamic contrast of imaging spectrometer more than ten-fold. Redesigned hardware to increase reliability. Developed the calibration protocol for final test and traceability purposes.

· Directed contract manufacturer in all scientific process control issues related to manufacturing the final product. Optimized design and assembly processes to increase spectral radiant flux by more than 50%.

· Assisted Intellectual Property Attorney with prosecution of United States and foreign patents of novel company technology.


UT MD Anderson Cancer Center, Houston, TX 12/2003 – 8/2007
Sr. Scientist (Sr. Statistical Analyst)

· Co-Director, Instrumentation Core of P01 grant (~$15M). Responsible for Quality and Security of clinically acquired data across North America. Project Lead for embedded real-time Quality Control software of research grade instrumentation for Phase II and III clinical trials. Assisted in clinical trial design.

· Manager and Director of 9 in the Engineering & Data Group (1.6Tb of data). Scientific Lead for team of physicians, engineers, and statisticians in analyzing spectroscopic data. Integrated statisticians, programmers, and engineers into a cross functional team increasing interaction and results.

· Project Lead for redesigning fluorescent spectroscopic fiber optic probe for enhanced light transmission and 8x reduction of probe autofluorescence.


Rice University, Houston, TX 8/1998 – 8/2004
Research Assistant and Postdoctoral Research Associate

· Designed novel methods to increase epidermal protection in response to laser irradiation

· Collaborated with physicians investigating laser treatment to reverse hearing loss

· Supervised four undergraduate students conducting infrared (FTIR) spectroscopic and radiometric measurements

· Quantified in vivo effects of laser-induced vascular response demonstrating optimal wavelengths for vascular coagulation

· Increased epidermal protection in response to laser irradiation allowing darker skinned individuals to benefit from cutaneous laser therapy


Candela Corp., Wayland, MA Summer 2001
Research Assistant

· Assisted R&D team in pre- and post-production R&D of medical laser systems

· Developed LabVIEW virtual instrument to monitor thermocouple and infrared temperature measurements

· Prepared written reports and white papers

· Researched viability of novel treatment using existing medical laser

Education

Rice University, Houston, TX
Ph.D. Bioengineering – Photomedicine Laboratory
2003

Louisiana Tech University, Ruston, LA
B.S. Biomedical Engineering, Electrical Engineering emphasis, summa cum laude
1997

Technical Skills

* Proficient in: MATLAB, Microsoft Office Suite, Windows OS

* Experienced with: MS Project, MS Visio, LabVIEW, AutoCAD, ImageJ, Adobe Photoshop, non-linear video editing, html, Adobe Acrobat, OSX

References

References available upon request.