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.
Our Project Leaders
Julie Kaiser-Braden brings over 20 years of experience to project management, product development, process transfer, manufacturing engineering, and quality systems.Read More
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.Read More
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.Read More
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.Read More
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.Read More
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).
Enrique possesses strong competencies in program management, and is specifically skilled in defining requirements, managing risk, and overseeing schedules.Read More
He also is skilled in resource planning, performing design verification and validation and managing supply chain definition and design transfer.
He has led medical device product development as well as healthcare applications. Enrique also brings entrepreneurial savvy with a diverse background with both startups as well as large corporations.
Ryan is a natural, high energy leader with a philosophy of employee development, empowerment, and sustainable long term improvements in performance.Read More
This leads to 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 ranging from medical devices to military programs.Read More
He is a versatile, results oriented proactive engineering Program Manager (PM) known for driving resources and launching high quality products to market quickly. 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).