Our Company

We have a diverse team of industry experts
who are world-class facilitators of change.

Our Leadership Team

Dodd StarbirdDodd Starbird, Managing Partner

Dodd Starbird has over 30 years of global business leadership experience in leading business transformation efforts that consistently achieve exceptional results by integrating best-in-class business process, technology, and human change management skills with strategic business management and leadership experience.

Dodd is the author of two business books, The Joy of Lean: Transforming, Leading, and Sustaining a Culture of Engaged Team Performance (Quality Press, 2016) and Building Engaged Team Performance: Align Your Processes and People to Achieve Game-Changing Business Results (McGraw-Hill, 2010).

He has a Bachelor of Science in Mechanical Engineering from the United States Military Academy at West Point and an MBA from the University of Denver. He lives in Atlanta, Georgia.

Teri MontzTeri Montz, Chief Financial Officer

As CFO and Controller, Teri is responsible for overseeing Accounts Payables, Accounts Receivables, Payroll, Human Resources, Benefits Administration and all daily financial operations.

Before joining the Implementation Partners Team, Teri Montz had over 7 years with the Internal Revenue Service and 20 years in Public Accounting, 15 of which she owned and managed a successful accounting and tax practice.

Teri has a Bachelor of Science in Accounting and Bachelor of Arts in Italian from California State University, Chico and is a Certified Public Accountant in the State of California.

Fred OlssonFred Olsson, Vice President, Client Engagement

Fred brings over 20 years of experience in Business Process Improvement to his role of Vice President of Client Engagement with Implementation Partners, LLC. He has worked extensively in the financial sector, with the bulk of his experience in the insurance industry. In his most recent role with a leading life insurance carrier, he was responsible for launching the Engaged Team Performance (ETP) program, leading Lean Six Sigma efforts with cross functional teams throughout the organization, and facilitating Kaizen events for specific opportunities. The ETP program culminated in a notable shift organization-wide into a culture of improvement and data-based decision making. He was responsible for incorporating new techniques, frameworks, and technological innovations, and he spearheaded the assessment of major improvement projects such as Robotic Process Automation (RPA).

Fred has been highly attuned to improving workplace morale through initiatives such as the ETP program and development of a companywide leadership program. The leadership program effectively provided mentorship and was designed to inspire, enhance, and retain quality associates across the organization.

Fred has a BS in Business Administration from William Jewell College (Liberty, MO) and an MBA from Baker University (Ballwin, KS). He is ALMI (Associate of the Life Management Institute), ACS-Life Insurance (Associate, Customer Service), and Lean Six Sigma certified. Fred lives in Kansas City, Missouri.

Terry ParkerTerry Parker, Senior Partner, Banking and Wealth Practice Leader

Terry Parker has been in the banking/financial services industry for over 30 years, with hands-on experience in credit and risk management, lending, corporate/commercial banking sales and relationship management and capital markets.

As a consultant to banks throughout the US, Canada, UK and Europe, he has worked extensively with clients to clarify/refine and build internal commitment/engagement to the bank’s strategy, as well as driving effective implementation of the strategy through improved role clarity, business and management practices/processes and team alignment. Terry is highly experienced at designing and using metrics to assess the progress of change efforts and employee engagement. His consulting experience includes: Corporate and Investment Banking; Middle Market and Small Business Banking; Credit and Risk Management; Private Banking; Wealth Management; Retail Banking; Brokerage; and Financial Markets.

Terry has a Bachelor of Business Administration degree from The University of Notre Dame and is a founder and Managing Director of Strategic Performance Partners LLC.

Tiffani SiddonsTiffani Siddons, Senior Consultant, Facility Design Practice Leader

Tiffani Siddons is an experienced industrial engineering strategist with a proven track record for designing and implementing world-class manufacturing and assembly facilities. For over 18 years she has played active roles in defining and executing company visions, working with global teams to support property strategies across the U.S.

In her most recent role as the facilities engineering specialist and program manager on a 3,000,000 sq. ft. campus revitalization project, she engaged with stakeholders to develop the project scope and then guided the team through planning and execution. As a part of the project, she tactfully defined and orchestrated a 4000+ asset movement plan without inhibiting ongoing production. Among numerous facilities projects, she has successfully led an entire $30 million work package to construct and populate a state-of-the-art aerospace composite manufacturing facility.

Tiffani has a strong mind set for continuous improvement and is proficient in incorporating Lean Six Sigma methodologies throughout her projects – resulting in significant bottom-line savings for her customers. By optimizing overall facility layout designs for process and material flow, she enabled a $4 million hard savings on a recent project.

With data-driven integrity, Tiffani enjoys engaging teams by building simulation models and providing 2D, 3D and 4D computer aided designs (CAD) to facilitate understanding and enable the team to visualize their efforts and overcome challenges ahead of implementation.

Tiffani received a BS degree in Industrial Engineering from Purdue University. She is accredited in Lean Six Sigma and is a certified Project Management Professional (PMP).

Her passion for making a vision become reality is contagious.

James StarbirdJames Starbird, Senior Consultant, Technology Practice Leader

A certified Lean Six Sigma Black Belt, James leads our Technology Strategy and Digital Transformation practice. This is complemented by his expertise in the areas of business operations improvement. He has worked in the public and private sectors in technology (SaaS), financial services, consumer products, healthcare services and distribution logistics industries. He specializes in driving process improvement efforts by combining business operations and technology strategy methodologies to develop holistic solutions.

In previous roles, James has worked with Sales Operations teams in an effort to drive business process optimization, tasked with defining and leading strategic technology and business initiatives. He has also led efforts in the identification and implementation of operational and organizational structure opportunities. Complementing his experience in technology strategy and deployment, James has experience with business process improvement, business intelligence, and advanced analytics.

James has a BS in Business Management from the University of South Carolina’s Moore School of Business and an MBA from Northeastern University’s D’Amore-McKim School of Business.

Our Team

David AthonDavid Athon

David Athon has spent most of his career introducing Lean Enterprise principles into manufacturing and transactional environments. He has developed a unique method of integrating Six Sigma and Lean into a single, balanced system. As a certified instructor in both Six Sigma and Lean, David has been educating and consulting since 1996, starting with Lean Enterprise and Continuous Improvement methodologies, adding Six Sigma to his abilities in 2000. A Master Black Belt, David combines practical knowledge with excellent communication/coaching skills to enhance students’ understanding and retention of the Six Sigma / Lean Methodologies. He has been responsible for providing training and mentoring to all levels of organizations in both Six Sigma and Lean methodologies including Steering Committees, Champions, Master Black Belts, Black Belts, Green Belts and Lean Practitioners/Experts. He has held full time positions in Apparel, Metal Office Furniture, Sheet Metal, Aerospace and Commercial Air Refrigeration. David has worked with a wide range of different industries including Consumer Products, Manufacturing, Medical, Pharmaceutical, Chemical, Insurance, Finance, and Telecommunications, helping his clients deliver tens of millions of dollars of economic benefit.

David has a BS in Industrial Engineering Technology from Southern College of Technology in Marietta, Georgia.

Jim AthonJim Athon

Jim has a strong background of Continuous Improvement, having held positions as an Industrial Engineer, Manufacturing Engineer, and Design Engineer. He received his Black Belt training in 1996 while at AlliedSignal Automotive and generated substantial benefits for the organization in both the Manufacturing and Transactional areas. He later held positions as a Black Belt and Master Black Belt at GE Industrial Systems.

Jim has been consulting for over 17 years. He has experience in several industries, including: Paper & Printing, Automotive, Consumer Electronics, Aerospace, Internet Service Provision, Healthcare, Pharmaceuticals, Life Sciences, and Medical Insurance, amongst others. Jim also collaborated with the Penn State QMM program coaching and certifying Graduate Black Belt candidates.

Jim has led numerous projects for clients utilizing Lean principles and Six Sigma problem solving, such as changeover time reduction, establishing pull systems, improving equipment reliability, and eliminating defects. He has also implemented Lean Sigma deployments for a variety of clients, most recently a petroleum refinery that generating $44MM in hard dollar benefit in 2015. He has trained over 800 Black Belts and numerous Green Belts, as well as coaching and mentoring over 1000 projects. He has a unique ability to communicate to any audience at any proficiency level and is skilled at enabling others to understand complex concepts by using commonly understood language and examples specific to their industry and projects.

Jim has a Bachelor of Science degree in Textile Engineering and a Six Sigma Master Black Belt certification.

Becky BaybrookBecky Baybrook PhD

Becky has a passion for developing organizations, teams and individuals to drive business results. She is an entrepreneurial, innovative HR leader focused on practical, scalable people practices that drive business results, integrate cultures and operating styles, and bring out the best in talent.

Dr. Baybrook offers real-world tested expertise in the following:

  • Global M&A: Managing due diligence, talent and culture-fit assessment, benefits and pay practice assessment, communication and integration planning, and execution
  • Organization design: Providing a sounding board and expert guidance on designing an organization and developing capacity to deliver on strategic commitments

For over 20 years, in a range of high-tech and media companies, Becky has led culture and organization transformations. Most recently, Becky has worked with Life Sciences, Medical Device, and Property Management companies as their People Strategy & Practice consultant. Prior to that, Becky was Global Chief People Officer for Saama (big data solutions consultancy); VP Human Resources for Echelon (embedded control networks), Nanosolar (a solar startup), SST (a fabless memory chip company acquired by MicroChip) and for PDF Solutions (a process technology consultancy). She started her career with Knight-Ridder, Inc. a large media company (acquired by McClatchy).

Becky received a B.A. in Psychology from Westmont College and a Ph.D. in Organizational Psychology from the University of South Florida.

Sarah BrethouwerSarah Brethouwer

Sarah’s passions are for people and processes. Her diverse background in human resources, healthcare, operations, and information technology enables her to holistically drive process improvement, change management, innovation, and Engaged Team Performance as an on-site project leader.

With project and senior leadership experience ranging from machine shops and hospitals to banks and insurance companies, she has deployed Lean, Six Sigma, and Engaged Team Performance tools to deliver results for clients in healthcare, manufacturing, and transactional/service industries, with an emphasis on implementing process changes, designing new workflow systems, managing team performance through both daily measures and trend analysis, and working with senior leaders to drive organizational change and strategic initiatives.

In her most recent role for a top Denver hospital system, Sarah has supported clinical and operational projects for patients across the care continuum (inpatient to outpatient) for three nationally recognized and top 10 sub-specialty service lines and now supports and drives the organization’s healthcare Innovation Strategy. She brings cross functional and cross level teams together to execute on quality, operational, cost savings, innovation and clinical outcomes, and she gets to know her clients’ operational and clinical team members just as well as the leadership in order to consistently strike the right balance in aligning people and processes for success. She also serves on many hospital-wide groups aimed at aligning practices and ensuring safe and efficient outcomes for patients and staff.

Sarah has a Bachelor’s of Business from the University of Wisconsin, Oshkosh, with majors in Human Resources, Operations Management, and Management Information Systems. She is a certified Lean Six Sigma Master Black Belt, and also is gold-certified in Engaged Team Performance.

David ClineDavid Cline

David Cline has over 35 years of business leadership experience, having held multiple executive roles in manufacturing and transactional environments. He has extensive experience in operations, strategic planning and strategy, manufacturing, leadership coaching and development, employee engagement, team building, process management, quality improvement and balanced scorecard key process indicators (KPIs) and analysis. He has been a leader and key contributor in organizations to drive continuous improvement.

David is a motivational manager, a persistent coach, and an expert in inspiring teams to solve problems and achieve excellence. As an analytical champion of reducing waste and obtaining high levels of employee and client satisfaction, David has led over 100 projects utilizing Strategic Planning and Lean Six Sigma principles such as production cell design, Kanban replenishment, visual controls, leader standard work, and eliminating defects.

David has a Bachelor of Science in Economics from the University of Alabama in Birmingham. He is a certified Lean Six Sigma Black Belt and is gold certified in Engaged Team Performance. He lives in Rockwall, Texas, with his wife and enjoys golfing and travel.

Debbie Curl-NagyDebbie Curl-Nagy

Debbie Curl-Nagy is an experienced consultant and trainer, with a focus on Leadership Development and Lean Six Sigma training, coaching and project facilitation.  She has over 15 years of experience developing and providing training, consultation, and technical assistance in continuous improvement, evaluation, leadership, critical thinking and effective decision making to a variety of audiences.  She is also an experienced facilitator, enabling organizations and teams to achieve desired outcomes through effective planning, facilitation and group decision making.

Debbie brings a wealth of experience from her work in health care, education, public and non-profit organizations.  She has provided Lean and Six Sigma training, coaching, and project facilitation to health care, education and social service organizations across the country.  In her work with the Veterans Health Administration, Debbie has worked with executive and mid-level leaders to develop a Lean Management Infrastructure that transforms the organizational culture in order to promote, sustain and disseminate continuous improvement throughout the organization.  She has also taught basic through advanced Lean and Six Sigma courses; and facilitated Rapid Process Improvement events within public, nonprofit and private organizations.

Debbie was previously employed as Director of Collaboration and Continuous Improvement for a national nonprofit organization providing consultation and technical assistance to community partnerships focused on improving urban education.  She has worked in government as a state performance auditor and project manager to promote efficiency and effectiveness of public programs; has run programs and taught bachelor’s and master’s level courses in Social Work; and has worked in the non-profit sector providing crisis intervention and counseling services to children and families.

Debbie has a Bachelor of Arts in Psychology from Bowling Green State University and Master of Social Work from Louisiana State University.  She received her Six Sigma Black Belt from the International Society for Six Sigma Certifications in November 2010.

Crystal Davis

Crystal Davis

Crystal Davis is an experienced business management consultant and leadership development coach with over twenty years of experience in the design, development, and implementation of Lean Business System solutions. She has accumulated extensive domestic and international expertise in automotive, healthcare manufacturing, and consumer packaged industries.

Crystal has assisted clients in formulating comprehensive business and logistics strategies and in re-engineering distribution and manufacturing operations to reduce costs, improve customer service and drive sustainable revenue gains.

With Crystal’s vast knowledge and experience, she has played integral roles on several enterprise-wide Supply Chain Management projects. Crystal has also trained and coached globally in Operational Excellence at various organizational levels. As a teacher, consultant, coach and speaker, Crystal uses practical techniques, innovative methods, and Socratic teaching to engage, captivate, and add value to those she encounters.

Crystal holds a B.S. in Industrial Engineering, a M.B.A; is a certified LSSBB, and a certified John Maxwell Leadership Development Coach.

Steve GreenSteve Green

Steve Green has over 25 years of federal government and private industry Lean Six Sigma and Management Systems consulting experience in multiple industries and environments.  He is passionate about process improvement and facilitating teams to achieve results.

Steve is a retired United States Air Force (USAF) veteran.  During his service he held senior positions leading efforts that resulted in substantial achievements in Supply Chain and personnel support operations.  He also served as a civil servant for with the USAF where he held senior positions as Enterprise Architect for Supply Chain Operations business processes, and later as Course Director/Lead Instructor for the USAF Lean Six Sigma Black Belt course.  He brings in-depth process improvement experience including defining and executing strategies, implementing management systems, curriculum development and delivery, training, coaching, and mentoring.

As a consultant and certified Lean Six Sigma Blackbelt, Steve has in-depth experience leading multifaceted process improvement teams delivering sustainable improvements.  His experience and knowledge coupled with his ability to motivate and facilitate change has enabled teams to reduce operational cycle times and waste, and to improve quality while delivering exceptional product and customer experiences. Steve has worked with teams and executives in the Healthcare, Automotive, Safety, and Medical Supply industries.

Steve earned a Master’s of Science in Management degree from Troy University in Troy, Alabama.  He also received a Bachelor of Science in Occupational Education, Major Business Administration from Wayland Baptist University in Plainview, Texas.

Melanie GuanciMelanie Guanci

Melanie Guanci has over twenty years of experience in client-centric process management with a focus in organizational and employee development. She currently contracts in a role as the Communications Director for Joppa, an organization serving homeless individuals in Iowa. She also serves on the Board of Directors and is a past CEO of the Lupus Foundation of Iowa. As a quality improvement specialist, Melanie is a strategist in achieving key business objectives.

Experience areas include:

  • Team Building and Development
  • Training/Train the Trainer
  • Process Improvement and Problem Solving
  • Call Center Dynamics
  • Key Performance Indicator Improvement
  • Building Client Centered Cultures
  • Functional Strategy
  • Organizational Development
  • Sales and Relationships
  • Business and Non-Profit Operating Models
  • Facilitating Change in both Culture and Operations

Melanie has a BS in Business Management, Employee Development. She has a professional record of increasing revenue, reducing costs, building teams, and creating lasting cultures, with a focus and passion for serving the community in non-profit organizations. She lives in Des Moines with her husband and children.

Jim JanickiJim Janicki

Jim Janicki has over 25 years of global business leadership experience in consulting, business operations, business strategy, manufacturing, systems, quality, engineering, regulatory, sales, and supply chain management.

Jim was one of the original certified Black Belts in GE’s Six Sigma program and went on to become a founding certified Master Black Belt and Lean Master for Sun Microsystems’ Sun Sigma program, where he was then promoted to lead the corporate-wide Operational Excellence effort. His team trained and certified 40 Master Black Belts and 420 Black Belts in an organization of 32,000 people. The program achieved benefits of cost savings and new business from improved customer engagement of over $1 billion in a three-year period.

Jim is a registered professional engineer and holds three U.S. patents, and he published an article in the first edition of iSixSigma magazine. Jim also volunteers as a board member on the Industrial and Professional Advisory Council for the College of Engineering at The Pennsylvania State University.

He holds a Bachelor of Science in Chemical Engineering from The Pennsylvania State University and an MBA from Western Michigan University. He lives in Maryland.

Rodney JarrettRodney Jarrett

Rodney has over 25 years of sales/marketing, management consulting, and executive advisory experience.  Over the course of these years, he has been a strong advocate for an “outside-in” process design philosophy rather than the traditional “inside-out” or inwardly focused orientation for undertaking process optimization, believing that understanding a customer’s desired outcomes and experience expectations are the best launching points for innovative and profitable process improvement.

Most recently, Rodney was the Chief Operating Officer at an Intelligent Automation systems integrator where, as Project Executive, he supported one of the largest deployments of Robotic Process Automation (RPA) in the government healthcare insurance operating environment.  In the first nine months of production, the new system eliminated an estimated 8 million manual Customer Service Representative searches; now performed by software robots.

Rodney’s background in Cognitive Document Automation, Machine Learning, RPA and his expertise in document-centric Intelligent Process Automation, workflow consulting, and associated solution development has led to similar results elsewhere:

  • Consulted with the executive operations team at one of Australia’s leading financial services firm to improve the delivery of wealth management and retirement products and services with an estimated reduction in operational costs of $2.8M per year.
  • Guided the financial management team of a global media and entertainment conglomerate to eliminate uncollected revenues due to the inability to refute questionable credit card charges. Prior to the implementation of the new system losses exceeded $100,000 per month.
  • Provided guidance to a large regional health insurance carrier in the automation and transformation of their commercial appeals process, decreasing expenses by an estimated $1.5M.

Rodney holds a Bachelor of Arts in Economics from the University of South Florida, Tampa Florida campus and earned a Master of Business Administration with a specialization in Technology Management from the University of Phoenix, Orlando, Florida campus.  Rodney is a certified Lean Six Sigma Green Belt awarded by Purdue University’s College of Engineering, a Prosci certified Change Management Practitioner, and a Medallia Institute certified Customer Experience Professional.  Additionally, he has received university level certifications in Lean process improvement, business analytics, and change leadership from the University of Central Florida, the University of Pennsylvania, and Cornell University respectively.

Kelly KitaKelly Kita

Kelly brings over 16 years of experience in process-based organization design, measurement, and problem-solving. Her focus is on custom-designing an improvement approach for her clients that works with their company’s unique culture, people, and business goals to achieve speedy results. Kelly’s practical approach was honed in her years in management with American Express, GE Capital Corporation, and Target Corporation, where she had lead roles in the development and launch of change initiatives ranging from Baldrige-based business assessment, to process re-engineering, to Lean Six Sigma. She has helped to bring success to both the traditional and the non-traditional targets of process improvement – including distribution, operations, information technology, marketing, human resources, and more.

Kelly has a proven track record in working across all levels of the organization. For example, she has led senior management teams in defining the organization’s core processes, determining process-based business metrics, and selecting improvement projects that helped to achieve their strategic initiatives. She has also established and coached project teams, and achieved up to 40% improvement in performance. Further, she has led international training teams, with audiences that ranged from Executives to front-line employees, and programs that integrated classroom and e-learning tools for higher efficiency and effectiveness. Kelly’s diversity in experience and expertise helps to ensure her clients they are provided the best services and solutions to meet their needs.

Kelly holds a M.A. from the University of Minnesota, Minneapolis, and a B.A. from the University at Albany, New York.

Mimi KokoskaMimi Kokoska

Dr. Mimi Kokoska is an experienced executive leader in value-based care, operations, network quality and strategic innovations and technology in health and payer systems.

She is the Chief Executive Officer and Co-founder of Accend Health, a healthcare management consulting company providing organizational audits, strategic and data insights, population health, customizable artificial intelligence platform and operational excellence to health systems, payers, employers and medical groups.

Dr. Kokoska’s prior roles highlight her expertise in organizational growth, quality, and affordability. She was the Senior Vice-President of Strategic Partnerships & Innovation and Accountable Care Organizations at Blue Shield of California with over $20B in revenue, where she assessed and enhanced large health systems and medical groups to increase network growth, quality, and value for over 4 Million members. As Senior Vice-President and Chief Medical Officer of Hospital Based Specialties in Aurora Health Care (now Advocate Aurora), she led the achievement of many system “firsts”, improving patient access, quality of care and its P&L. As Service Line Director, Vice-Chair and Professor with Tenure at Indiana University Health and Indiana University Health Physicians, she led and managed several successful surgical quality initiatives. She served as the Chief Surgical Consultant responsible for reviews of seven facilities across Michigan, Indiana, and Southern Illinois in the Veterans Health Administration, which were recognized as top 3 out of 130 systems in the country. Dr. Kokoska has been recognized for healthcare quality, patient safety, operational effectiveness and costs, whilst mentoring future leaders.

Dr. Kokoska earned her MD from Keck University of Southern California School of Medicine, a Master in Health Care Management from Harvard School of Public Health and a Black Belt in Lean Management. She is Board Certified in Otolaryngology-Head & Neck Surgery and Facial Plastic and Reconstructive Surgery. She serves on the Board of Directors and Senior Advisor for the American Board of Facial Plastic and Reconstructive Surgery (2001-present). As a member of the board for Rebuilding Together Oakland | East Bay, she advances health equity through housing equity and safe and healthy homes.

Rachel LambRachel Lamb

Rachel is a results-oriented professional with demonstrated ability to deliver continuous improvement initiatives that have added millions of dollars to the bottom line. She has extensive experience leading, training, and mentoring through the use of problem solving and Lean tools. In her most recent role as the Global Head of Process Capability for Defense Services at Rolls-Royce, she developed and implemented a Lean Acceleration program. This program enabled teams across the sector to rapidly maximize business performance through on time delivery, efficiency gains, and cost reduction solutions. She is characterized by a strong set of values and high levels of initiative and commitment. Her goal is to combine her knowledge and fifteen years of process improvement experience to deliver optimal results for clients.

Rachel has a BS in Industrial Engineering from Purdue University and a Master of Science in Manufacturing Management from Kettering University. She is a certified Lean Six Sigma Black Belt and certified Project Management Professional (PMP). She spent several years of her professional career working in Mexico where she became proficient in Spanish.

Gina LaBella TulinGina LaBella-Tulin

Gina LaBella-Tulin has over 20+ years’ Life Science industry and consulting expertise in quality and regulatory working with medical device, pharmaceutical, and combination product companies. She is an expert in product lifecycle management with a process improvement and project management approach leading cross-functional teams though design and development, clinical requirements, and post market surveillance.

Gina is an expert in building the process, procedural infrastructure, and implementation for Quality Management Systems  for compliance to ISO:13485:2016, 21CFR 820, and EU MDR  through conducting Design Control and DHF gap assessments/audits and remediations. Her quality system work also includes considerable experience in CAPA/Complaint Handling and Medical Device Reporting (MDR), Risk Management, and Supplier Controls.

Among her recent projects include:

  • Leading a Quality Management System design/build for a pharmaceutical company for compliance to 21 CFR 820, ISO 13485:2016, and EU MDR in the manufacture of their first combination product, a pre-filled syringe.
  • Providing a point-of-care quantitative in vitro diagnostic (IVD) assay and diagnostic system instructions for use (IFU) manual and Human Factors clinical study protocol to support an FDA submission.
  • Leading a Design History File (DHF) gap assessment, training, hazard analysis, and risk/benefit analysis related to clinical and risk requirements for a combination product company for compliance to EU MDR, 21 CFR 820, and ISO:14971 Risk Management.
  • Conducting clinical trial site Pre-Approval Inspections (PAI) to assess readiness for commercial manufacturing, data integrity, and conformance to application in support of a pharmaceutical company NDA submission.
  • Leading a Quality System Gap Assessment/Audit and remediation for an international combination product company for compliance to FDA CFR 820 and ISO 13485:2016 requirements with an emphasis on design controls, complaint handling, CAPA remediations, & post market surveillance.
  • Providing Investigational Device Exemptions (IDE) process and procedural expertise for a pharmaceutical company standardization of their combination product portfolio to support their conduct of clinical studies.

Gina holds a Master of Science degree in Biology from Delta State University and is a certified ISO13485:2016 Lead Auditor.

Jena MarcumJena Marcum

Jena Marcum has broad experience leading projects, programs, and process improvements for a variety of industries. She is known for her ability to consistently deliver results by breaking down ambitious projects into executable plans and strategies. Jena has led the planning and execution of multi-year global technology projects among cross-functional teams including engineering, legal, test, manufacturing, supply chain, purchasing, and operations. She also volunteers as a Project Management Professional (PMP) Instructor for the Project Management Institute (PMI) and as a Wish Granter for The Make-A-Wish Foundation.

Her previous career experience includes Engineering and Technical Program Management at Rolls-Royce Corporation where she worked with the U.S. Air Force, U.S. NAVY, NASA, Italian Air Force, Alenia Aeronautica, General Electric, Pratt & Whitney, Lockheed Martin, and Cessna on various development and in-service programs.

Jena earned her Bachelor’s degree in Aerospace Engineering from Embry-Riddle Aeronautical University and her Master of Science in Technology degree from Purdue University. Jena holds PMI PMP and Lean Six Sigma Green Belt certifications, and she is a Certified Scrum Master (CSM) and a Scaled Agile Framework (SAFe) Product Manager/Product Owner.

Staci Nayeri

Staci has spent her career partnering with operations leaders to drive improvements. She is the Chief Analytics Officer and co-founder of Beyond Benchmarks, a company that focuses on enhancing process improvement efforts through operational analytics. This goes beyond simple benchmark comparisons to competitors. They get deep into the detail of operations and help teams make the right improvements.

Staci’s previous roles include Business Analytics Director and Lean leader at Indiana University Health, Industrial Engineering leader at Fiat Chrysler Automobiles, and Industrial Engineer at the Walt Disney Resort. Her notable accomplishments include launching an innovative team at Indiana University Health which provided business intelligence reporting, predictive analytics, simulation, workforce management and scheduling support. At the Walt Disney World Resort, she implemented a highly effective attraction efficiency program, developed space requirements for the largest Downtown Disney expansion to date, and prepared for the launch of FastPass+ by increasing FastPass availability by 20,000 tickets per day.

Staci has a Bachelor of Science in Industrial Engineering from Purdue University and is completing an MBA from Indiana Wesleyan University. She is also Gold certified in Lean.

Carlos RojasCarlos Rojas

Carlos is a design and innovation enabler who has helped organizations shape the conditions that make them more adaptive, creative, and prolific when solving modern business challenges.

A builder at his core, Carlos is known for his expertise in reimagining all aspects of an organization and for effectively setting a clear and compelling enterprise strategy that expands current offerings reach and profit revenues by: identifying target market growth opportunities, developing new differentiating offerings and capabilities, and positioning a corporation’s short and long term readiness to effectively engage the evolving domestic and global consumer landscape.

He draws from his passion for customer empathy and customer-driven innovation, twenty years of experience at three Fortune 500 corporations, and a range of disciplines that serve as a tool belt for reshaping culture, structures, talent, processes, products, services and experiences.

Born and raised in Cochabamba, Bolivia, where he also completed most of his studies, Carlos earned both his industrial engineering and marketing undergraduate degrees from Universidad Privada Boliviana and his M.B.A. from the University of Florida.

Beth RothwellBeth Rothwell

Elizabeth (Beth) Rothwell provides expert facilitation for strategic business decisions, particularly for the medical devices and venture capital industries. She is currently a Board of Directors member for the three VFD Technologies companies.

Formerly, she served as a Vice President for Monterey Advisors, a Medical Device consulting firm. From 2002 to 2008, she held several executive positions with Kyphon, Inc., one of the fastest growing medical device companies in history. These positions included Vice President, Operations, Quality, R&D, Program Management and Regulatory Affairs. From 1995 to 2002, Beth served as a Board of Director Member and Vice President for Intercon, Inc. a contract manufacturing firm specializing in fiber and electrical assemblies for a variety of markets.

Ms. Rothwell holds a M.S. in Biomedical Engineering from Virginia Polytechnic Institute and a B.S. in Ceramic Engineering from Alfred University. She is also a graduate of the Harvard Business School’s Women in Leadership Program.

Josh SimonsJosh Simons

Josh Simons is an experienced manufacturing systems implementation leader with over 15 years of experience implementing capability step-changes in production IT systems and maturity. Broad knowledge across a wide spectrum of manufacturing software systems and development environments. Adept at converting customer goals and requirements into solid production solutions. Specialized experience in new facility and production line design and optimization. Demonstrated aptitude for information systems integration and training.

In recent experience, he led manufacturing execution system (MES) selection and implementation for multiple new manufacturing facilities including a large greenfield aerospace composite Research and Development facility and a high-volume modern production facility.

Josh has led quality system development and manufacturing systems solutions as Quality Manager for a state-of-the-art advanced turbine manufacturing research facility.  Managed global implementation of new MES systems in several tier-1 aerospace manufacturers. Designed, built and effective custom digital shop floor solutions.

Josh received a BS degree Mechanical Engineering Technology from Purdue University, a MS degree in Innovation, Leadership & Technology from Purdue University.  He is an accredited Lean Six Sigma Black Belt and is a certified Project Management Professional (PMP).

Deanna SuskovichDeanna Suskovich

A certified Master Black Belt in Six Sigma and Lean Management, Deanna has worked with Fortune 50 organizations, government agencies, hospitals, labs, animal science, universities, architecture, engineering, and construction firms, as well as a variety of service organizations, to design and build continuous improvement programs; select, educate, and build clients’ change-resource capacity; and implement process improvement projects.

Deanna specializes in leading healthcare Lean Six Sigma deployments, with recent experience in leading and coaching projects for the Department of Veterans Affairs (VA) as a member of their internal consulting team, the Veterans Engineering Resource Center (VERC). She has invested almost a decade in support for that deployment, coaching executives in the MyVA transformation, leading champion workshops for leaders, training black belts, and facilitating rapid process improvement (RPI) efforts. She has also supported Lean Six Sigma deployments in other healthcare systems, including Memorial Hospital (Jasper, IN), Tipton Memorial Hospital (Tipton, IN), DuPont Hospital (Fort Wayne, IN), Indianapolis Coalition for Patient Safety, Sisters of St. Francis Health Care System, and the AHRQ – MRSA North America Collaboration.

Through the use of Lean, Six Sigma, and Design for Six Sigma methodologies, Deanna has educated and led on-site client teams on more than 140 Lean Six Sigma improvement and Design for Six Sigma projects which combined have an 83% success rate of sustaining improvements for longer than 6 months following the pilot implementation.

Deanna has a Lean Six Sigma Master Black Belt and a BA degree in Marketing from Purdue University.

Elisabeth Swan

Elisabeth has provided process improvement consulting, training and design services to Fortune 100 companies for the past 20 years. Most recently she worked on the design and implementation of a Performance Management System for the Bahamas Telecommunications Company resulting in the alignment of strategic corporate goals with every layer of the company down to coordinated targets for front-line technicians.

Just prior to that she coached several improvement teams at Charles Schwab resulting in a 20% reduction in unnecessary account terminations, a 30% reduction in rework associated with on-line funds transfers, a 75% reduction in total account open cycle time from application to funding. In an ongoing effort, she has been a principal in the design and rollout of the first Lean/Six Sigma effort in the hospitality industry for Starwood Hotels and Resorts resulting in average benefits of $30 million per year from 2001-2008 for North America alone.

Elisabeth is the author of a business simulation used worldwide to gain buy-in and establish leadership awareness in the area of process improvement. Her clients include: BP, Charles Schwab, Cisco Systems, GE Capital, Fireman’s Fund Insurance, Federated Department Stores, Johnson & Johnson, Kodak, Mitre, NBC, Northrup Grumman, Target, NBC, Raytheon, Starwood Hotels & Resorts Worldwide, United Health Care, Vanguard Financial Services, Volvo and Wells Fargo,.

Born in the UK, Elisabeth holds a bachelor’s degree in English from Columbia University in New York City, NY. Elisabeth is a certified Black Belt Trainer with GE Capital and a founding member of BCT (Boston Comedy Theater) specializing in improvisational techniques to foster organizational change efforts.

Tiffany Tokarz

Tiffany Tokarz

Tiffany Tokarz is the CEO of Modern Muse and an Intentional Growth Strategist. Since 2006, Tiffany has been working with sales professionals and business owners to help them achieve notable career and business advancements. Some of the industries where she has focused her efforts are the financial sector, manufacturing, engineering, veterinary services, and construction.

Tiffany holds credentials as a CPBA, CPMA, and has earned a master’s degree in Leadership and Organizational Development Psychology. She was recently accepted into Faculty Row, an elite organization of accomplished academics ranging from Fulbright Scholars to TED Talk speakers.

Tiffany believes that we have only begun to understand the scope of human potential and that leaders who create company cultures to better leverage their human capital will position their companies to thrive in the new economy. She prides herself on being results-driven while maintaining a healthy balance between work and play. Taking her own advice, Tiffany can often be found jogging at Gray’s Lake in Des Moines, teaching yoga, and attempting to cook something new in the kitchen.

Robert TrippRob Tripp

With over 20 years of focus in the quality management arena, Rob’s breadth and depth of experience combine to enable significant business results in each of his client engagements. Rob was trained and certified as a Six Sigma Black Belt in AlliedSignal’s first wave in 1995; by 1998 he acquired his Master Black Belt certification, at which time he began his consulting career. Since that time he has trained, mentored, and certified thousands of Green Belts, Black Belts and Master Black Belts in dozens of companies across several industries around the world. Through these engagements, Rob has assessed organizational readiness, designed and led deployment strategies, developed curricula for various levels of Lean, Six Sigma, and Design for Six Sigma training, and mentored Leaders, Champions and Belts through both organizational and technical aspects of Lean Six Sigma deployments. Rob is a thought leader in his profession, with several articles in website and print publications, and his clients have been recognized for deployment excellence and best deployment of the year multiple times at industry symposiums.

The continuous improvement journey that Rob has shared with his clients enables him to immerse himself in multiple processes across various functions, including R&D, sales and marketing, engineering, operations, human resources, accounting, information technology, and supply chain management. This process experience comes out of multiple industries, including mining, oil and gas, construction, automotive, chemical, insurance, banking and finance, software development, medical instruments, pharmaceuticals, and retail. Rob has delivered training, facilitated projects, and consulted deployments in over 20 different countries; prior to his consulting experience, Rob was an operations manager and plant controller at AlliedSignal.

Rob currently lives in rural Indiana with his family on a small hobby farm; he attended Indiana University, Bloomington, where he earned a bachelor of science in Biochemistry and an MBA in finance.

Susan VaughnSusan Vaughn

Susan has over 22 years of consulting experience, specializing in both traditional and Agile project management. She has a proven track record of managing challenging information technology projects and is a results-driven professional with experience leading multifunctional teams of experts in initiating, planning, executing, controlling, and closing complex projects. She has expertise in facilitation, requirements gathering, and design documentation and possesses great analytical skills and is a creative problem solver.

Susan is a board member of Women & Hi Tech, a non-profit organization created to address the specific needs of women in high tech industries in Central Indiana that encourages more women to consider careers in technology. She has been actively involved for over 13 years and a board member for 11 years.

Susan received a business degree specializing in computer information systems from Indiana University’s School of Business and she is a certified with the Project Management Institute as a Project Management Professional (PMP).