Tom Waddell is the owner and CEO of Waddell Group and the co-founder and former co-owner of Project Leadership Services/PLS Inc. With an extensive history as a leader and senior consultant in the medical device industry, Tom has expertise in technical project management, small company executive management, product development and process reengineering. Tom holds a BS in Electrical Engineering from the University of Wisconsin-Madison.
Vice President of Sales
Rich Gall brings over 15 years of business to business sales experience, networking, and connecting interesting intelligent people to other like-minded people to the Waddell Team. He has driven double digit growth for several technology services firms year over year. More than just a pure contact for sales, he generally gets handed the more difficult client issues to solve. Along the way he looks to connect technology thinkers with technology makers.
Easy going and easy to talk to, Rich has a background in classical education and that shows itself in the blog posts he writes and the creative thinking he brings to his work at the Waddell Group. In addition to leading sales efforts, he handles responsibilities from recruiting, identifying Project Manager/client fit to representing the Waddell Group at events. Driven, entrepreneurial and with high integrity, Rich fits right in with the Waddell Group
Our Project Leaders
Tom Waddell is the owner and CEO of Waddell Group and the co-founder and former co-owner of Project Leadership Services/PLS Inc.
With an extensive history as a leader and senior consultant in the medical device industry, Tom has expertise in technical project management, small company executive management, product development and process re-engineering.
His expertise also extends across industries, including medical products, semiconductors, manufacturing, finance and government. Regardless of the sector, his skills of setting direction, problem solving and motivating teams have generated successful outcomes in project management, product development, operations, engineering and executive management. Moreover, Tom has a proven track record in strategic planning and working with teams to help them achieve organizational objectives.
Tom holds a BS in Electrical Engineering from the University of Wisconsin-Madison.
Patrick Besanson has over 25 years of domestic and international experience managing the start-up and growth of medical and technology-based companies.
An expert in both product development and operations management, Pat is a focused team leader and successful problem solver. His unique skill set is further enhanced by strong analytical and creative abilities, along with a talent for integrating the human, technical and financial elements of a project.
Not surprisingly, some of the world’s most demanding businesses have engaged Pat to manage key initiatives. In the initial stages of a product’s life, Pat typically oversees product development, process validation, technology transfer and acquisition integration. As the project progresses, he shifts attention to production start-up, manufacturing expansion, site selection, facility planning and ISO / GMP Compliance.
Pat holds a BS degree in Electrical Engineering from Marquette University in Milwaukee as well as an MBA from the University of St. Thomas in St. Paul, Minnesota.
John Vasicek brings over 30 years of diverse, hands on experience to every project with a proven track record of results delivered for clients both large and small. His results are achieved through the application of leadership, focus, initiative and effective communication of objectives and expectations.
A background in Operations, Supply Chain, Manufacturing Engineering, Quality, Product Development and Commercialization allows John to inspire optimal performance across multi-functional project teams to achieve superior outcomes. Products brought through development to commercial release include implantable cardiac pacers, defibrillators, cardiac re-synchronization devices, drug delivery catheters, neuro stimulation leads, monitoring and diagnostic devices, surgical instruments and accessories. John understands how to optimally negotiate the path through product development, process development, supplier development, reliability testing and regulatory submission.
Primary industry focus during his career as a Consultant has been in the Medical Device Industry, however, John has been engaged on DOD projects and a variety of Contract manufacturing operations.
John holds an MS in Manufacturing Systems from the Univ. of St. Thomas, a BA in Management/Admin. from Metropolitan State and professional certifications from APICS, ASQ and SME
Lynn Ihlenfeldt has more than 20 years’ experience developing and commercializing medical devices. Her professional experience includes working within large companies, startups, and service companies. In addition to significant experience with cardiovascular devices, Ms. Ihlenfeldt’s experience includes low- to high- risk devices and such emerging fields as wearables. She has held executive management positions at Minnetronix and Lantos Technologies.
Ms. Ihlenfeldt currently advises medical device companies on product development, project management and supply chain to execute an efficient and effective path to commercialization.
Ms. Ihlenfeldt has a Bachelor of Science degree in Computer Science from the University of Wisconsin and an MBA from the Carlson School of Management, University of Minnesota.
Julie Kaiser-Braden brings over 20 years of experience to project management, product development, process transfer, manufacturing engineering, and quality systems. Her area of expertise is in project management, with emphasis on difficult-to-manage or troubled ventures. Recognized for her ability to step into projects in motion, she moves quickly to assess project status, prioritize needs, and ensure completion within deadlines. Julie’s record of achievement extends across industries, including biomedical, automotive and filtration. Working with all sizes of companies, she has led projects ranging from medical device and quality systems development to technical services and the development/start-up of analytical services labs. Complementing Julie’s inherent leadership skills are her sense of urgency, decisiveness, analytical reasoning ability, and unwavering commitment to completion. She also brings to projects a goal-focused, global perspective that enables her to tackle complex endeavors by breaking them down into workable segments. The fact that she is a seasoned manager with the ability to communicate clearly at all levels within an organization makes her an even more effective leader. Julie is an alumna of the University of Minnesota’s Institute of Technology.
Jonathan’s specialty is building strong, capable teams. During his 25 years in medical device, he has worked at start-ups with 10 employees and multi-national companies with 20,000. He has managed large functional organizations, can’t fail R&D programs and worldwide business process change initiatives.
With focus areas in complex business process change initiatives, transitional management roles and R&D program management, Jonathan has a track record of taking on projects that are troubled or ambiguous and working within all levels of the organization to bring focus and clarity.
His intellectual curiosity and critical thinking drive him to develop domain expertise rapidly, earning him the respect of high performing engineers early in the team building process. This, combined with a strong propensity for strategic business thinking provides teams with perspective on what is most important to the business.
Jonathan holds a degree in Mechanical Engineering from the University of Minnesota and a Masters Degree in Mechanical Engineering from University of California, Berkeley.
Project Manager PE, PMP
Theresa Kimler is a dynamic and resourceful Project Manager with a passion for developing and bringing out team excellence. She looks at the big picture and bridges project management structure with lean and six-sigma tools and techniques to create the most effective approach to the unique project at hand.
Her field of experience is diverse, having worked in manufacturing and business process improvement, quality, process validation, supplier development, and human factors usability validation. She is experienced in managing multiple cross-functional projects and teams and leading them through change initiatives. Her project management experience extends across medical device and consumer products industries for over 20 years.
Able to quickly get up-to-speed on project environments, team dynamics, and the technical side of the work, Theresa is able to translate complex problems into clearly understood and focused projects to get the team moving in a unified and productive direction.
Theresa is a Project Management Professional (PMP), trained in Six-Sigma and Lean tools and techniques. She graduated with distinction from the University of Minnesota with a BS in Mechanical Engineering and is a licensed Professional Engineer (PE).
Wayne Bass has over 40+ years of medical device process engineering experience in product development and manufacturing, specializing in leads and cathaters.
In his process engineering experience, Wayne’s focus has been in supporting or leading manufacturing teams in product/process development and management to schedules. He has led 20+ products through manufacturing concepts, process development, tooling and fixturing development and process qualification/validation (IQ, OQ, PQ) and into commercial release. In this role, Wayne has trained and qualified manufacturing facilities around the world including a high-volume facility in Puerto Rico, a research facility in Europe and a low volume facility in Asia.
Wayne has extensive knowledge in mechanical crimping processes, laser and resistance welding, silicone and polyurethane adhesive applications, press fitting of mechanical components, plasma cleaning, silicone molding and drug solution application. He recently worked on implementing a new surgical drape product/package and validation, including coordinating final product specifications with outside vendors, internal material and process specifications and required builds for characterization, validation, sterilization and commercial release.
Wayne holds a Green Belt Certification through Medtronic, trained in Six Sigma principles, DRM, Lean manufacturing and DMAIC principles. He holds four US patents.
Henry Pak has over 25+ years of broad life sciences experience ranging from academic research to industry R&D and management consulting.
His consulting has focused on product development and technology management in the life sciences arena. He has managed projects (pharmaceuticals, medical devices, healthcare providers) in Product Strategy and Development, Quality/Regulatory, Sales/Marketing, Supply Chain/Operations and Technology Management that have resulted in significant value over a broad range of metrics from small start-ups to major Fortune 50 healthcare companies.
In the academic/corporate research arena, Henry has been involved in an eclectic mix of basic and applied research projects including development of automated immunodiagnostics, medical device development, development & commercialization of advanced drug delivery systems, neurophysiology of evoked potentials, epilepsy therapeutics (drug, device), laser angioplasty, ultrasound 3D color imaging, chronobiology and the complexities of drug-device combination products.
Henry has a Biomedical Engineering degree from Northwestern University, a Masters in Bioengineering from the University of Illinois and a Masters in Engineering Management (MEM) from Northwestern. Mr. Pak is certified as a Six Sigma Black Belt (CSSBB), Auditing (CQA), Organizational Management (CMOE), Quality (CQE), Reliability (CRE), New Product Development Professional (NPDP-pending renewal) and Project Management Professional (PMP).
Enrico Westenberg has 25+ years of experience in product development and project management, with more than 10 years in medical devices.
He has broad experience in product launch and operational yield improvement while forming and leading teams in Europe, Asia, Brazil and USA. He has a Master of Chemical Engineering with a thesis on the use of membranes to clean flue gases. He received an MBA from the University of Minnesota.
He has made automotive parts for the cars, detergents for a cleaning chemicals firm, launched hard drives for global leader in data storage, and developed cardiac leads/pacemakers for the medical device industry. He has also managed healthcare software teams.
He gained formal consulting experience while at McKinsey & Co as implementation coach and initiated various remediation projects in the medical device space. One of his strengths is to tailor his management style to everyone’s natural state to maximize contributions to the team. Enrico has credentials as a certified quality engineer (ASQ), project management professional (PMI), scrum master (Scrum Alliance), Green Belt (Seagate), and certified manager of quality / operational excellence (ASQ).
Ryan is a natural, high energy leader with a philosophy of employee development and empowerment which leads to achievement of sustainable, long term improvements in performance, business and leadership growth as well as highly engaged and happy employees. Known as an innovative thinker, change agent and evangelist with a passion for creating a Lean Enterprise and a Continuous Improvement culture to achieve Operational Excellence.
Consistently called upon to contribute or lead innovative projects and key initiatives.
Continuously improves safety, quality, delivery, cost and morale/engagement by teaching, coaching, and empowering employees to think Lean, apply Lean tools and principles and create a sustainable Lean management system and ultimately a Lean Culture.
Specialties: Leading Change Lean Tools; Lean Production System; Lean Management System; Lean Culture Creation/Development; CI Continuous Improvement Culture; OE Operational Excellence Culture; Medical Device Manufacturing; FDA TUV ISO Regulated Environments; Process Development; Project Management
Charles . Gilbertson, P.E.
Management Consultant / Program Manager
Chuck Gilbertson has over 35 years of experience as a leader in multiple industries. He is a versatile, results oriented proactive engineering Program Manager (PM) known for driving resources and launching high quality products to market quickly. He is successful in industries ranging from medical devices to military programs. He interacts with a diverse set of constituents from customers at all levels to other professionals to assure their needs/expectations are met for existing, new, and next generation products.
Chuck is notably accomplished in: Remediation/Program/Project/Product management, product design, engineering, intellectual property, quality assurance & regulatory compliance, e.g. ISO13485, IEC60601, MDR, MDSAP, MEDDEV & CER; customer interface & business development leadership and creative development & manufacturing product related problem solving. He has completed medical device DHF & remediations and managed global CRRT product development. He is known to be within the top 5% of performers and is the recipient of a ‘Chairman’s Award’ for exemplary performance.
He has a BS of Mechanical Engineering – Institute of Technology (UofM) & licensed Professional Engineer (Master Degree Equivalent).