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.

Donor car found

After deciding that I wanted to do an Electric Vehicle (EV), I needed to pick what I would convert. Nearly all home conversions use an old ICE (internal combustion engine) auto. So I was looking for a car with a blown engine, that wasn't too old, had a curb weight of less than 3000 lbs, manual transmission, lots of space for batteries, and a GVWR of 1000 lbs more than the curb weight for the added battery weight. A Jetta seemed to fit the bill. I really like the Mark 4, but the likelihood of finding a 5 year old car that is not worth repairing the motor was slim. I looked at a Mark 2, but it smelled old on the inside. I eventually found a good shape Mark 3 with a blown diesel engine in October 2006. The seller was a nice guy and he dropped the price if he could keep all the engine parts as he wanted to a Toyota diesel conversion later. So for $1000, I got myself a 1998 Jetta TDI with front disk brakes, a sunroof, pretty nice sound system, keyless entry, electric door locks, and A/C. I think it a bit ironic that I ended up with a diesel even when going electric.

Since my friend Norman (who affectionately calls the eVdub the death trap) has a Ford F250, he was recruited to pull the eVdub across Houston to its new home. Since I was on crutches from blowing out my knee again, I had Trey (who I ran into playing basketball when my ACL tore) come along, too. I wish I had pics, but it took longer than we thought and it was getting dark. I've got a little body work to do, but she'll be pretty silently rolling down the SW Freeway.

The funny thing about the pic below is that near the end of 2006 we received a letter from our Home Owner's Association letting us know about a (barely) sagging gutter and that we needed to get it fixed within the week. Little did they know that directly below that 'hideous' gutter was a car with only HALF an engine. he he

"Guess what crazy hobby my husband is into now...."

The title is a typical saying of what my wife says when I start something new. It's not that she doubts me, but rather my hobbies are so esoteric, that she's never heard of them before. See here and here for another, what my Rice labmates called, "crazy" hobby of mine.

I guess that it started about a year ago and I got sick of wildly fluctuating gas prices AND giving my hard earned money to Dictators who hate America. I first investigated going straight grease, aka SVO or WVO, in a diesel car or ginormus truck. I was basically resigned to either driving a 25 year old Mercedes with all its quirks and needed rapairs or a $20k Ford 250 with 150k miles. Either way, if it breaks down, I'm hosed and out a bit of money, as I'm not mechanically inclined (I've never even changed my oil before). I also looked into making my own biodiesel, but you must be very precise in measuring and mixing chemicals or your engine is toast. I don't like chemistry; I'm not that precise. The other thing that took me away from SVO and biodiesel is that in order to at least not get behind financially, you have to go to mom-and-pop restaurants and get their old waste grease. Messy and yucky.

Trey, a friend at work suggested an electric car, but I quickly dismissed him. But it got me thinking, I essentially have a minor in electrical engineering, and if I could remove 60% of the moving parts in a vehicle, I would be that much better off. After pondering it a bit, the only thing holding me back was "how am I going to mate the electric motor to the transmission?" The Internet is a beautiful thing, as I found a company who does just that ElectroAutomotive. They have many templates for common conversions, and if they don't have your pattern, you can send them your bell housing and they'll make one for you.

Now that I convinced myself that my alternative fueled (read: not giving money to terrorists) vehicle would be electric, I needed to find a suitable donor car. My major criteria were: 1) it had to be cheap and 2) my wife wanted a car that she won't be ashamed of (ie not a 1980 Ford Escort) sitting in the driveway every evening.