OUR TEAM…OUR MOST VALUABLE ASSET

JOHN K. ZEIS

PRESIDENT

John manages the company’s engineering/design staff and projects here at Toolbox Medical Innovations. Over the years, he has grown and fostered strong relationships in the medical device and diagnostic community. These friendships will serve as one of the key pillars of Toolbox’s growth.

Before starting Toolbox Medical Innovations, John founded a successful product development company, which he managed for 10 years before selling it to expand his range of services to the medical device and diagnostics community. John is an expert in diagnostic device development and speaks several times per year on the subject at various conferences and events.  He is listed on over a dozen patents, ranging from point of care diagnostics to drug delivery devices.

Previously, John worked in R&D at Medtronic’s interventional cardiology division developing stents and their delivery systems. He also worked at Quidel developing diagnostic products and manufacturing processes to scale these products up to tens of millions annually. His early experience in manufacturing engineering is an asset as he guides the staff and advises clients on design for manufacturing, materials and process selection. He received an MBA from University of Phoenix and a BS in Manufacturing Systems Engineering from Kettering University.

PAUL C. RYAN

VP OF BUSINESS DEVELOPMENT

Paul is a seasoned executive with over 25 years of experience in global business development, sales, cross functional management, marketing, product and project management. He thrives on building relationships and business through serving and fulfilling the needs of each and every client. Prior to joining Toolbox, Paul worked in a wide array of high-tech industries growing them to their maximum potential. He is a dynamic and results-driven professional driven by passion and excellence.

Paul has a BA in Communication from San Diego State University and enjoys spending his free time with family and friends in his favorite place on earth – San Diego, CA.

GRANT A. WARE

BUSINESS OPERATIONS & MARKETING ASSISTANT

Grant is pursuing his Bachelors Degree in Business Finance at California State University, San Marcos. His hope is to become a financial expert and help businesses, individuals, and charitable organizations thrive. He has a diverse role at Toolbox Medical Innovations including hands-on experience business operations,accounting, marketing, and business development which complements his education. In addition to this, his mechanical background serves him well as he is able to assist as an engineering technician.

When away from school and work, he is passionate about motorcycles, traveling, and the outdoors. He would rather collect motorcycles than cars, and can often be found on offroad motorcycle trips. Whenever he gets a chance, Grant travels to a new place and loves learning about different cultures. He is confident that his education, work ethic, and personality will contribute to his growing success.

CHRIS C. DA COSTA

SR. PRODUCT DEVELOPMENT ENGINEER

Chris is a highly specialized life sciences and diagnostics engineer local to Southern California. He has worked on several molecular diagnostic devices, DNA and protein purification, genome mapping, sample collection, storage, and processing devices as well as micro and meso fluidic technology. Chris has worked with Invitrogen (later Life Technologies), and was recruited from his last company to work for Toolbox Medical Innovations. He has a BS in mechanical engineering from Cal State University in Fullerton and works on his jeep perfecting his mechanical skills every weekend in his garage, dessert, or on the racetrack. In addition to his rock crawling and pit crew for Ultra4 racecar, Chris enjoys mountain biking, baseball, and his boxers, Roxy and Cammy.

DAN GUSSIN

SR. PRODUCT DEVELOPMENT ENGINEER

Dan Gussin has 15 years of IVD and molecular diagnostic expertise encompassing the molecular assay fundamentals from his BSc in Biochemistry and MSc in Molecular Medicine and his extensive product and systems engineering experience in product design and development, and developing lean manufacturing semi-automated processes across numerous technologies (microarrays, sequencing, immunoassays, electrochemistry, cyclic voltammetry) measuring at sensitivity a variety of biomarkers whether cellular, hormonal, or foreign. Since at Toolbox, Dan has worked on IP generation and strategy, designing new manufacturing lines, managing product development projects, and supporting new clients through requirements building, risk definition, and conceptual designs.

KAMEEL ABI-SAMRA, PH.D

SR. PRODUCT DEVELOPMENT ENGINEER

With a Ph.D. in Biomedical Engineering and more than 9 years of experience developing medical devices, Dr. Kameel Abi-Samra is a vital asset to the Product Development Team at Toolbox Medical Innovations. Dr. Abi-Samra has helped to develop a wide range of microfluidic-based in vitro diagnostic devices (IVD), such as automated systems to facilitate Next Generation Sequencing (NGS), disposable sample-to-answer devices for infectious disease detection, and blood collection tools. Evidenced by his several publications in the field, he has pioneered several technologies that advance the field of IVD and Lab-on-a-Chip. For example, he has developed tools to study the performance of lateral flow strips and has generated numerous solutions for the field of Lab-on-a-Chip by innovating novel techniques for liquid handling, reagent storage, sample preparation, and bio-marker detection.

AYMAN M. IBRAHIM

SR. PRODUCT DEVELOPMENT ENGINEER

Ayman has been a product development engineer for nearly 25 years. He’s had the privilege to work in many industries from Consumer, Commercial, Industrial, Military, and Medical. Developing products from industrial and medical instrumentation, toys, medical devices, military hardware development, biometrics, to mechatronics. He has a very wide and diverse portfolio of product development and uses his knowledge in injection molding, metalcraft, and CNC work to apply his expertise. Having worked at companies such as Nelcor, Cardinal Health, Apogen Technologies, Sanyo, L1 Identity Solutions, and Lifeproof to name a few. He enjoys satisfying his constant curiosities for knowledge in the strangest places, being a charter member of KOOK (Keepers of Obscure Odd Knowledge). He enjoys spending relaxation time with his wife, surfing, working out, home improvement, getting out to the gun range, and being at the beck and call of his boxer supervisor, Bucky.

DANIEL J. BRAUN

SR. PRODUCT DEVELOPMENT ENGINEER

Daniel Braun received his Bachelors of Science in Mechanical Engineering from University of California, San Diego in 2006. Following his graduation, he worked for SPAWAR, a Navy R&D lab in San Diego, California as the lead Mechanical Engineer for the Unmanned Maritime Vehicle Laboratory. While full-time employed, he completed his Masters of Advanced Studies degree in Medical Device Engineering from UCSD in 2013. Following his graduation, he transitioned into the field of medical devices by taking the role of lead engineer at DrugArray in La Jolla, California. In 2014 he took a position as Sr. Product development engineer for Toolbox Medical innovations. Daniel’s background and expertise are in rapidly transitioning R&D technologies through their product lifecycle consisting of design conception, proof of concept testing, fabrication, production, and distribution.

DOMINIC AIELLO

Senior Product Development Engineer

Dominic has over 12 years of industry experience developing medical devices in the diagnostics, therapeutics and surgical instrumentation sectors. He has designed and engineered IVD consumable products which have been commercialized and released to the market. Dominic believes in the quick-turn of concepts to testable parts, all while adhering to quality system standards, to strengthen his engineering and development efforts. Machining technologies are a big interest and Dominic’s desire is to be versed in machining fabrication to aid in his design and engineering efforts.

Dominic received his degree in Mechanical Engineering from the University of Colorado in 2004. In his free time, he enjoys snowboarding and fly fishing with his dog, Mateo.

TYLER MANIACI

Product Development Engineer

Tyler is a unique mix of engineering excellence and ingenuity, seasoned with a great practical aptitude from hands on experience. He looks at things from a different perspective, seeing simplicity in complex problems, and visualizing realistic, practical solutions. He thirsts for knowledge and enlightenment and is driven by his curiosity and a desire to make things better. Tyler is a skilled craftsman in many disciplines which influences his engineering design work and implementation.

Tyler graduated from San Diego State University with a Bachelor’s of Science in Mechanical Engineering. He started out his career working in the Oil and Gas industry and has since moved into Medical Device and Biotech industries. In his free time, he loves nothing more than to spend time with his wife and kids.

CEDRIC BETHANY, PH.D

Product Development Engineer

Cedric is a BioMechanical Engineer specialized in the Design and Manufacturing of BioMEMS and Biomicrofluidic Systems for Cell Biology assays. He has been involved in several national and international multidisciplinary research programs focused on the development of microsystems for various applications such as Cell-to-Cell communication assays in cancer, ELISA on a Chip, Blood analysis, Cell isolation, molecular diagnostics. Cedric has complementary years of manufacturing engineering experience in the medical device and the aerospace industries. Cedric holds a BS of Mechanical Engineering from the University of Technology at Troyes, France, a M.S. and a Ph.D of Mechanical Engineering from the University at Buffalo and PostDoc experience from UNIST, South Korea and the University of Michigan. Cedric has worked in 4 Different Countries over the course of his career, he has authored over 10 Scientific peer reviewed articles and has participated in several international conferences on the subject of Biosystems.

COLE PAULSON

PRODUCT DEVELOPMENT ENGINEER

Cole is a high energy product development engineer that has worked for big name companies such as Biomet and BD Biosciences.  Most recently, he worked for Ortho Development designing custom orthopedic instruments for surgeons.

A preference for fast-paced innovation has led him to the Southern California biotechnology start-up scene. His can-do Midwestern attitude and natural inclination toward creative solutions ensure deliveries are always on time. Cole considers versatility a virtue. From the whiteboard, to the shop, to the executive presentation – he’ll be there.

Cole acquired is mechanical engineering degree from Kettering University in Flint, MI. When he isn’t busy with work, you might find him climbing rocks, biking mountains, or walking beaches.

ERIC A. WARNER

SR. PRODUCT DEVELOPMENT ENGINEER

Eric has over 20 years of experience in mechanical engineering, mostly with a focus on medical and diagnostic devices. He is extremely well rounded In addition to CAD design, he is an experienced machinist with his own CNC mills and lathes and does his own injection molding.

His specialties include IV and peristaltic pumps, laboratory equipment, orthopedics, microfluidics, manufacturing fixturing, and software coding. In the past he has worked with PDA, Hunter Industries, IVAC (now CareFusion) and has run his own consulting company for the past 15 years working for medical device companies including notable companies such as Dexcom and Illumina.

Eric graduated from University of California, Irvine with honors in civil and mechanical engineering. When he isn’t busy at work, you can find him on the water in his sailboat or making music on his banjo, mandolin, or with his family.

PATRICK COFFEY

SR. PRODUCT DEVELOPMENT ENGINEER

Patrick is an accomplished technical manager, engineer and scientist with nearly two decades of experience developing diagnostic instruments and disposable fluidic cartridges. He has led multiple teams through challenging medical diagnostics development projects for medical device companies under the guidance of FDA QSR 21 CFR Part 820. His technical background is in physics (BS, MA) and engineering (BS) with specializations in instrumentation, optics, microfluidics and systems engineering.

He has served as an engineer at the Johnson Space Center, coding algorithms for the International Space Station and spent time working on particle detection at Los Alamos and Brookhaven National Laboratories. Over the past 15 years he has developed and worked on numerous fluidic assay and microfluidic systems for protein crystallization, cell electrophoresis, visual and fluorescence lateral flow assays, evanescent coupling assays, time resolved assays, microfluidic fluorescent immunoassays, microfluidic colorimetry, and electrochemical microfluidic systems for IA, small organics and electrolytes. From 2002 to 2013 he served as a senior scientist at Biosite and principal scientist at Alere. He currently serves as a consultant to Toolbox Medical Innovations and is the founder of IVD Vision LLC which specializes in instrumentation to read photometric based assays.

MARIA BAUER

ENGINEERING TECHNICIAN

Maria is a Ph.D. student in Mechanical Engineering with focus on electrochemical detection and microfluidic systems. She obtained her Master’s degree in Mechanical Engineering and Management at the Technical University of Munich, Germany. Before joining the team at Toolbox Medical Innovations, she worked at a Rapid Prototyping facility as well as in the automotive and manufacturing industry. Besides traditional manufacturing and prototyping technologies, Maria has experience in various Micromanufacturing, Additive Manufacturing, and characterization methods.

JENN SALZETTI ZEIS, CCRP

VP OF CLINICAL OPERATIONS

Specializing in medical device and diagnostic clinical trials, Jenn manages client’s clinical trial needs.  With almost 25 years of clinical research experience in the IVD industry, Jenn and her team have a proven track record of coordinating, executing and monitoring successful clinical trials.

Prior to joining the Toolbox Medical Innovations team, Jenn ran a successful consulting business managing several companies’ clinical trial programs. During that time, she consulted for BD Diagnostics, Alere, Genzyme Corporation, Sekisui Diagnostics, Innovacon, Acon, UpSpring Baby, Applied Biotech, Conception Technologies, Skin Medica, Binax and Universal Biosensors.

Through this work and her previous experience at Quidel Corporation, she developed strong contacts with several physician office laboratories, hospitals and laboratories with pediatric, women’s health, cardiology, toxicology and general practice clinical research experience.

COLLEEN MONACO, CCRA

CLINICAL RESEARCH MANAGER

After receiving a B.S. at Southern Connecticut State University, Colleen moved to California. She went on to the extension program at University of California, San Diego, to earn the specialized certificate in Clinical Trials Administration and certification through ACRP as a CCRA.  With close to 20 years of clinical trial experience, Colleen has worked primarily on in vitro diagnostic and medical device studies.  She spent almost a decade monitoring with DOCRO, a leading diagnostic oncology contract research organization specializing in diagnostic biomarker clinical trials.  Working as a consultant to several CROs and as an independent monitor, she has both monitored and managed dozens of IVD studies as well as specimen collections for bio repository at hospitals, labs and physicians offices across the country.

AFTON ANDERSON

CLINICAL RESEARCH ASSOCIATE

Afton received her Bachelors of Science in Biology and Minor in Leadership from the University of Minnesota, Twin Cities. Following graduation, she joined Exosome Diagnostics, a biotech company in St. Paul, MN, focused on liquid biopsy diagnostics. She successfully managed oncology studies, which played an integral role in commercializing the company. In the process, Afton created and improved systems for efficient clinical monitoring and budgeting. Prior to that, Afton refined sales and marketing skills at Vector Marketing as a Sr. Field Sales Manager and Branch Manager. Leveraging her marketing and clinical skill sets, she has become a key player in managing and growing clinical operations at Toolbox.

When not working, you can find her working out, reading, and FaceTiming with her nephew.

TAMMI ARMSTRONG

CLINICAL RESEARCH ASSOCIATE

After a few years as an RN on medical surgical, orthopedic and oncology units, Tammi Armstrong received her Masters of Science in Nursing from the University of Toledo/Medical College of Ohio. She initially focused her attention on teaching and inspiring students at St. Vincent’s School of Nursing. She provided both classroom and clinical experiences in acute and long term care settings. One of her first recollections of being interested in clinical research was from being an active member of St. Vincent Medical Center’s Nursing Research Committee. For the past 15 years Tammi has been the Vice President and Co-Creator of preschool/early childhood centers known for their services, facility and community of excellence. Tammi was instrumental in designing the centers with health promotion/illness prevention in mind. Her can do attitude, strategic planning, attention to detail and her ability to break complex concepts into more manageable pieces make her a great addition to our clinical study team.

JENN CROSSE, CCRA

CLINICAL RESEARCH ASSOCIATE
Jennifer
 has almost 15 years’ end to end clinical trial project management experience, to include medical device trials, government studies, patient outcomes research, health economic research, observational and workflow studies.  She has experience in a wide arena of therapeutic areas to include diagnostics, infectious diseases, respiratory, oncology, gastroenterology, cardiology, pediatrics and diabetes.  Jennifer received her B.S. in Biology from the University of North Florida, and is currently completing her M.B.A. in  Leadership from Towson University.  She has been CCRA certified through ACRP since 2011.

MELISSA DSOUZA

Clinical Research Data Associate

Melissa recently earned her Master of Public Health Degree with a concentration in the field of Biometry/Biostatistics from San Diego State University. While pursuing her degree she worked at the California Department of Public Health within the Infectious Disease Epidemiology team where she assisted with the development, improvement and maintenance of the Binational Border Infectious Disease Surveillance database and was also responsible for reporting of binational cases to the World Health Organization as part of the Binational Infectious Disease Surveillance Program. She significantly contributed to shortening of data entry times and improving the efficiency of the CalREDIE (online health records) system. Melissa, also holds a Master of Science in Virology and is passionate about Infectious Diseases research, Clinical Research and Applied Biostatistics.
 

BARBARA STEVENS

REGULATORY SPECIALIST

Barbara Stevens provides quality system and regulatory consulting support to manufacturers of in-vitro diagnostics and medical devices. Ms. Stevens has over 40 years of experience in Regulatory Affairs, Quality Assurance, and other technical areas in the IVD, medical device, pharmaceutical and biologics industries, including middle and executive level management positions as well as consulting projects. Areas of expertise include quality systems design and implementation, regulatory compliance, premarket submissions, CE mark, clinical trials, documentation, labeling, and validation. Ms. Stevens received a B.S. in Chemistry Education from the University of Illinois, is RAC certified, and is certified by ASQ as a Certified Quality Auditor (CQA) and Certified Biomedical Auditor (CBA). She is a former SDRAN board member and is also a member of RAPS, OCRA, ASQ, and the American Association for Clinical Chemistry.

LEAH GUDIEL

USABILTY SPECIALIST

Leah Gudiel is a Human Factors Specialist with a background in design and marketing. Leah graduated from California State University, Northridge with a B.A. in Graphic Design and a M.A. in Human Factors and Applied Psychology. She has been a Human Factors consultant specializing in usability testing for both verification and validation of medical devices since 2011. She also has experience in task analyses, software usability evaluations, creating prototypes, concept sketches and flow charts.                                                                                                                 

BUCKY M. IBRAHIM

THE SUPERVISOR
Hard work and efficiency, some of our keys to success here at Toolbox, and our newest supervisor, Bucky, ensures it. When Bucky is not running and swimming, he uses his expertise to grow a business. His salary of cheese and treats is funded by his owner, Ayman, one of our senior engineers. Here at Toolbox, we provide a friendly and inviting atmosphere for both employees and our valued customers. This tremendously helps with our success and makes us unique. We are proud to serve our community and Bucky’s glare keeps us on task.

 

OBI-WAN KENOBI

JEDI MASTER
A legendary Jedi Master of napping, Obi-Wan is a noble dog and gifted in ways of the sleeping and eating Force. He is temporarily on hiatus from Toolbox as he masters the obedience Force!

 

TWIGSLEY PETERSON III, PhD.

ACADEMIC ADVISOR

Twiggy’s title is Academic Advisor and here is his bio: Twig is the resident Academic Advisor for Toolbox. He is regularly consulted on the technical issues involved in day-long naps, bully-stick mastication efficiency, risk assessment of parked vehicles, and the development of innovative belly-rub techniques. As a close companion to Daniel Gussin, Twig can periodically be found snuggled up by a window. His endless pursuit of affection and treats makes for his general reliability as an employee.

MATEO (TEO) AIELLO

Sr. Chillin’ Out Engineer

Teo is the king of all things mellow. A comfy bed, carpet or sunbathing are his usual locales. Don’t be fooled by the perpetual puppy-dog face and concerned looks as this is only his ploy for getting the scraps during Friday BBQ’s.
A mountain dog at heart, he’ll perk up for a day on the river and is new to the beach scene.
Mateo has great expertise in the laid back arts and helps remind everyone to relax once in a while!