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.
Shelly Franz is a management consultant and executive coach with over 28 years of experience. As the Resource Manager for Waddell Group, Shelly brings insight, humor and operational excellence to our company, our consultants, and our clients – managing all of the back office activity and social events for the company. She is a graduate of St. Olaf College and has a masters in Public Affairs from the University of Minnesota.
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 established deadlines. Julie’s record of achievement extends across industries, including biomedical, automotive and hydraulic and automotive filtration. Working with large, small and startup companies, she has led projects ranging from medical device and quality systems development to technical services and the development and 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.
Gregg Chiponis has over twenty five years of diverse Product Development, Operations, Materials Management, Quality Systems and Facilities experience. In the fields of active and passive medical devices (Class I, II & III). He utilizes a highly participative, team building leadership style which establishes high personal performance standards with strong commitment to a client’s success. Gregg has excellent organizational, communication and analytical skills.
Gregg has staffed start-up organizations, completed facility relocations and new facility design/construction. He has successfully managed the ISO 13485 certification process and hosted many FDA inspections. Product development to commercial release products include active implantable medical devices (IPG & ICD), implantable hearing devices, cardiac occluders, catheters, guidewires, embolic filters, infusion ports and advanced bio-polymers.
Primary consulting focus for client’s has been constructing quality systems, defining verification and validation strategies, supply chain sourcing and facility start-up/operations. His specialty is a “hands on” approach to satisfying his client’s needs so additional staffing is not required.
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).
Enrique Malaret brings more than thirty-three years of experience to medical product development and regulatory knowledge. He has developed and launched numerous products and taken products through clinical trials to market release. Bringing his depth of experience to clients has assisted them in identifying complementary market opportunities, creating product development plans and manufacturing supply chains, and guiding them through the regulatory process.
Enrique’s expertise includes design & development projects to modify and extend pacemaker product lines, a wireless health monitoring system, an implantable fluidic system, and engineering of a cystic fibrosis screening system.
Program management and regulatory navigation skills have made Enrique successful at managing complex projects for FDA-regulated medical device companies and has provided him with a strong knowledge of regulatory affairs, clinical requirements and planning needs. He has also mapped out and established medical manufacturing supply chains for multiple products, including intracranial and intravascular pressure sensors.
Enrique brings business leadership skills and acumen from his multiple years running his own successful companies, and holds 10 patents. Enrique graduated from Lafayette College with a B.S. degree in Electrical Engineering.
Henry Pak has over 25+ years of broad life sciences experience ranging from academic research to industry R&D and management consulting.
In his consulting experiences, Henry’s focus has been on excellence in 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).
Rich Gall has a ten-year history of growing sales for nerdy companies. He has helped driven double digit growth for several technology services firms year over year. He has also helped small startup technology companies get off the ground. Along the way he looks to connect technology thinkers with technology makers. Rich leads the Waddell Group sales efforts.
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