



“There are certain individuals that immediately impress you with their intelligence, creativity, humor, and ability to distill and articulate complex concepts into simple layman’s terms. Brad is one of these individuals. I’ve had the pleasure of working with Brad on-and-off over the last 15 years. Initially, I worked under Brad as a software developer when Brad managed a large SW development team. Brad was a mentor for a number of us. He was adept at keeping the troops well informed of the big picture and continuously inspired motivation and cooperation to meet our goals. Later, I worked as a peer with Brad where he successfully developed and deployed numerous Quality System Design Control components. Brad has broad and deep knowledge of ISO/FDA regulations relative to medical devices. As such, Brad was instrumental and easily participated in numerous quality audits to support our design control practices and artifacts. More recently, I had the privilege of hiring Brad to consult and lead a Systems Engineering effort for a new product that had just entered the concept phase of development. Brad has the unique ability to quickly assimilate information, interact with people with multiple skill sets and personalities and make things happen. I enjoy working with Brad and hope to continue crossing paths in the future.”
Don Peters, Sr Manager Systems Engineering R&D, BD Biosciences (colleague)
“As a Quality Engineer at Abbott, I’ve had multiple opportunities to work with Brad on various projects. Brad’s significant experience in Design Controls, Quality Assurance, and Technical Analysis consultations on projects and processes I found invaluable. Brad has a grounded interpersonal approach to team work. He’s inspirational to work with, and takes time to participate on issues whenever requested. He is a detailed and very astute analyst of business challenges, and provides sound, pragmatic recommendations. He is highly experienced in product development lifecycles, especially as applied to medical devices. He has a gift making you smile, even in the most challenging of situations. I would fully recommend Brad for any position, and would enjoy working with him again.”
Steven Mattos, R&D QA/Software QA Staff Engineer, Abbott Diagnostic, worked with Brad at Abbott Laboratories, Diagnostics Division
“I’ve worked with Brad for over 15 years. He is very driven to solve the problem put in front of him – the whole problem, even the parts that you don’t yet recognize. And solve it he will: he will accomplish the goals you set, extend your perceptions, and mature your process in a business efficient way. He has a strategic mindset and systems engineering approach. His technical experience is in software development and medical device development process. His technical expertise is fundamentally ‘systems” and that gives him the innate tools to take on any instance, any instantiation – whether “product” or “process”. He can give you a run for your money with a thorough design review moments after being introduced to the topic. You don’t often find the combination of communication skills that Brad exhibits. He can teach the uninformed, motivate the jaded cynic, and wear down the uncooperative with sheer pleasant persistence. He is socially adept and versatile; an excellent mentor, educator and project manager. Occasionally more optimistic than analytic about people, he’s always cognizant and re-evaluating the situation so that there are no surprises. He communicates to executives and line workers with equal ease; expectations are set, updated and realistic.”
Amy Sams, Design Control Manager – R&D, Abbott Laboratories, Diagnostics Division, worked directly with Brad at Abbott Laboratories, Diagnostics Division
“Brad Gilbertson is a unique blend of high IQ and EQ – he is sharp and personable at the same time. Brad’s expertise in Quality Systems and Device Development is invaluable. I enjoyed a very synergistic alliance while working with Brad at Abbott and recommend him highly.”
Hilary Danehy, Learning and Development Manager, Abbott, worked with Brad at Abbott Laboratories, Diagnostics Division
“Brad is the consummate software and design control professional. He possesses a wealth of expertise and experience in systems and software development, Design Control, and Quality Systems, in promoting quality, organizational, and business excellence. He also possesses excellent oral and written communication skills, and excellent interpersonal, leadership, and organizational skills. He is a quick study in learning new concepts and technologies. Brad applies exceptional problem solving skills, effectively and efficiently, in analyzing and resolving complex scientific, technical, analytical, and business issues across functional lines. As a former manager, and as a colleague over the last 10 years, Brad fostered a collaborative environment across disciplines. His door was always open to offer support, advice, and help, or to just listen. I enjoyed working for and with Brad.”
Gary Evans, Software Quality Engineer, Abbott Diagnostics, worked with Brad at Abbott Laboratories, Diagnostics Division
“Brad is an experienced-detailed oriented person, and I really enjoyed working with him. He has a very impressive contextual outlook for software designs and very good understanding with his teammates. I like his presentations (“with a bottle of water”) , very informative and detailed.”
Haridas Puthiyapurayil, Sr.Software Engineer, Abbott Diagnostics, worked directly with Brad at Abbott Laboratories, Diagnostics Division
“As an Engineering Manager at Abbott Laboratories Diagnostic Division, I would like to say that Brad Gilbertson’s assistance to me, and my department, is excellent. Brad’s principal role is that of Systems Engineer. In that role, he provides guidance to the manufacturing and sustaining engineers on the component and subsystem interdependencies of highly complicated medical devices. In his declared role, Brad is a key contributor in the effectiveness of technical review meetings. His knowledge of our procedures, designs, and the greater regulatory environment assures that the correct questions are asked, answered, and thoroughly documented. Although this would be expected of a senior engineer in his role, Brad’s diligence, energy, and cooperative personality give him the ability to build consensus between competing views, and solve roadblocks rapidly and effectively. In addition, Brad is endowed with a uniquely inquisitive nature. Although he is quite adept at solving the immediate technical question, he looks beyond the obvious manifestation. Brad chases the root cause, whether it lies in component relationships, sub-system interdependencies, process controls, or even general operating procedures. Brad is not intimidated by the level of complexity, but is driven by a desire to see problems solved. In so doing, Brad not only relies on his own knowledge, but also seeks the opinions of the relevant experts at all levels of the organization. Once the problem is thoroughly understood, and the solution identified, Brad is often the champion of the change. He is willing to take ownership of the most basic change to a component, or the most complicated re-write of an operating procedure. I would be truly sorry to see him go. Although he is a resource shared by many departments and functions, I greatly appreciate the support he provides to my organization.”
Chris Mead, Manufacturing Engineer Manager, Abbott Diagnostics, worked with Brad at Abbott Laboratories, Diagnostics Division
“I’ve enjoyed working with Brad and learned alot during our many interactions. Brad is a strategic thinker and problem solver – seeing all levels of each situation and problem. He is as much confortable with the high level as well as the details. Brad also learns new concepts & technologies fast; and develops expertise quickly. His broad experience has made him very proficient in the development of systems through entire lifecycles, especially for medical devices, including knowledge of software development theory and practice. In addition he was a very helpful collaborator in Quality Systems and Design Control improvement projects.”
Josee Fauteux, Various, Abbott Diagnostics, worked indirectly for Brad at Abbott Laboratories, Diagnostics Division
“Brad Gilbertson partners and builds trust with Quality Assurance. He is the go to person for every Quality Engineer seeking Design Control Knowledge. He is often a bridge builder in Project Teams. Brad will often translate design control problems in such a way that Quality Assurance will comprehend and make a scientific assessment and compliance decision. This type characteristic in a person breeds cultural success in a company. Brad is the mastermind of Design Control for Abbott Hematology. He is the go to person for Trace Documentation, for Development Documents. He knows product development lifecycles, especially for medical devices. His strengths are knowledge of FDA regulated software development theory and practice. Alonso Diaz Senior Quality Assurance (R&D) Abbott Hematology”
Alonso Diaz, Senior R&D QA, Abbott Hematology, worked directly with Brad at Abbott Laboratories, Diagnostics Division
“Brad was a Design Control Manager when I joined the company. I have had the chance to receive trainings and listen to his speeches regarding to Software Design Methodologies and Software Design Life Cycles. I was very impressed by the humorous approach, lively presentations, and on top of all, the breath of knowledge that Brad had. Bard pays attention to details and yet never looses the big picture. He is a seasoned leader who can provide positive impact to any organizations.”
Charles Yang, Manager, Software Dev, Abbott Laboratories, worked with Brad at Abbott Laboratories, Diagnostics Division
“As a manager & mentor, Brad is the best! He is an active listener and an effective motivator. His advice and guidance is directly responsible for my professional growth. I learned more about Design Control, FDA regulations, and ISO standards from him than I could from any book. With a creative analogy, he can explain the most complex software algorithm to a non-technical person. He can engage an audience with the driest of presentations. And he can inspire a person to do their very best. Brad’s depth and breadth of knowledge combined with his strategic thinking make him the go-to guy for any topic at any level. It is not uncommon to overhear someone say, “Let’s go ask Brad.” I would consider it an honor to work with him again in the future.”
Karen James, EPHF Database Administrator, Abbott Diagnostics, reported to Brad at Abbott Laboratories, Diagnostics Division
“Brad’s comprehensive approach to defining problem-spaces, scoping impacts/trends, information mapping, and solution design is stellar. His ability to “hold space” for multiple, often divergent, outcomes…and to select or guide others to select the best one(s) has to be experienced to be believed…yes, he’s that good. He’s also an entertaining speaker who’s able to present complex concepts simply, using humorous analogies relative to real-world working culture. And let me not forget to mention he’s really, Really smart.”
Aimee Campbell, International Labeling Manager (Hematology), Abbott Labs, worked with Brad at Abbott Laboratories, Diagnostics Division
“Brad is very strong in Product Development in all phases from cradle to grave. He is a quick study on difficult technical concepts from many disparate disciplines and is able to get to solutions that make good sense from an organizational perspective. He is also adept at forming a collaborative and cooperative environment. I’ve always enjoyed working on his projects.”
Tim Gray, Sr Systems Engineer, Abbott Diagnostics, worked with Brad at Abbott Diagnostics
“Brad is one of the few people in the industry that can successfully and competently manage a software project to completion. Most software projects that I have worked on usually degenerated into death marches by the end. At Abbott under Brad, it was the best run and stress free project that I have ever worked on. The requirements and data models were very well defined and there was an actual believable project plan that was divided into work packages that logically grouped tasks. Instead of skipping testing, we strived for 100% code coverage and came close. The process was strict (FDA and ISO 9001 compliant) but somehow it was not overbearing. Brad’s title was Manager but it should have been Leader. He truly led us. He has not just the technical ability and proficiency in project management but he has incredible people skills as well. It impressed me that he always tried to get, clarify, and understand the facts before acting. I look very fondly back on the days when I worked under him as some of the best times in my career.”
Brian Gebbie, Software Developer, Abbott Laboratories, worked indirectly for Brad at Abbott Diagnostics
“I’ve either worked directly for or through a lower level manager for Brad while he was a Software Manager. One of his accomplishments that I have always admired was the Software Development Process that he developed for the high-end instrument that he was responsible for. It was simple, but thorough, and enabled quality software to be produced. Since then I’ve not seen a Software Development Process that was as complete. While he was loyal to the division, he also had the knack to be loyal to his employees without compromising his loyalty to this division. This caused the people reporting to him to be loyal to both him and the division. Which in turned enable the people who reported to him to be able to get more done then expected. Even though are careers have gone different directions, I still feel that I can approach him for honest advice.”
Scott Gerken, Software Test Engineer, Abbott Laboratories, Abbott Diagnostic Division, reported to Brad at Abbott Diagnostics
“As my manager & mentor, Brad was instrumental in furthering my professional growth. Brad has a keen understanding of software architecture and the processes to support the overall requirements. When faced with challenging issues, Brad offered his guidance and expertise and identified additional resources to meet the project timelines. Brad is a creative and effective leader who can provide a lasting and positive impact to any organization. I would consider it an honor to work with him again in the future.”
Ron Abidog, Network Manager, Abbott Laboratories, reported to Brad at Abbott Diagnostics
“I first encountered Brad in a contract role; I choose him to analyze a make/buy database decision for me based on his extensive database development experience. I was the acting software manager at the time and desperately hoping that we would run across a good, solid software manager candidate so I could get back to my beloved algorithms and requirements. Thank god that I did encounter and hire Brad, because he was the perfect candidate for our software development manager position and my boss transitioned him into that role as soon as the contract task was under control. We were transitioning from a ‘garage shop’ operation to a large company and needed to step up in our software process maturity almost instantaneously. Brad pulled it off! He brought his systems thinking, his extensive software development expertise and his software manager expertise and turned our little rag-tag group of developers into an efficient, organized, process-oriented group of capable folk. He had to add automated process, trace, reviews, and test regimens completely from scratch – we had JUST learned to write down requirements and bug reports on paper rather than holding them in our heads when Brad came to our rescue.”
Amy Sams, Systems Engineer, Abbott, reported to Brad at Abbott Diagnostics
“I worked for Brad for about 4 years in developing, testing and deploying large scare software applications for medical devices. Brad has a great understanding and vision of software architecture and design as well as the process of creating such products in for mission critical products such as medical device industry.He has an in-depth understanding of design control process, FDA and ISO requirements and software design process. He was a wonderful manager to work for.”
Abe Mamaghani, Verification and Validation Manager, Abbott Labs, reported to Brad at Abbott Diagnostics
“Over the many years I have known Brad, I have found him to be articulate, intense, driven and successful. He holds both his teams and himself to the highest standards of performance and commitment. He has quickly learned new technologies and mentored his staff to a fast adoption. Brad brings a strong systems understanding to all of his activities, including engineering, management, and interpersonal communications. When faced with new challenges, Brad identified the needs which had to be solved, found the best resources to meet those needs and led his team to a very successful conclusion, specifically the development of a dramatically enhanced product line. His ability to recognize and solve the technical, organizational, and management issues meant success in the projects we worked together on.”
Steve Misenheimer, Senior Staff Consultant, CriTech Research, was with another company when working with Brad at Abbott Diagnostics










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