The Network Partners Story

Tim Early, CPP, MBA

President

As the President and Co-Founder of Network Partners, Tim offers a unique perspective on how companies can exceed business and customer goals with smarter staffing and better processes — a principle that serves as the foundation of Network Partners. Tim started his career in packaging engineering and quality assurance engineering at Cordis Corporation, and has spent the last 25 years working in the medical device industry. Tim specializes in operations, quality control, R&D and senior management, and has held leadership roles with Zimmer, Millstone Medical, Boston Scientific Corporation and Dupont Tyvek®. Thanks to his background, Tim helps companies develop and maintain strategies that keep them at the forefront of business opportunity and innovation.

Karen Polkinghorne, MBA

Executive VP

Karen leads Network Partners’ sales and marketing efforts, creating critical connections between the company’s community of experts and their clients. Karen started her career as a packaging engineer for Schneider and Smith & Nephew, and has spent more than 25 years growing her experience in the medical device industry. Karen has served in engineering and marketing leadership roles with Dupont Tyvek®, Bemis and Onguard Systems.

Karen has extensive knowledge of industry standards, test methods and best practices related to medical packaging (ISO 11607, ASTM, AAMI, AORN). She earned a Bachelor of Science degree in Packaging from Michigan State University and a Master of Business Administration in Entrepreneurship from the University of Colorado Boulder.

Dean Molloy

VP of Client Solutions

As Vice President of Client Solutions at Network Partners, Dean is responsible for leading the client experience and service delivery. He works with medical device, pharmaceutical, and biotechnology manufacturing organizations to overcome difficult challenges with a mix of consulting and outsourced solutions. Working exclusively within these FDA-regulated life sciences industries, Dean partners directly with each Client’s technical leadership to design and deploy the most appropriate mix of tactical and strategic consulting resources for any phase of the product lifecycle.

Prior to his current role at Network Partners, Dean was a Vice President of client services with Validant Consulting. In the role he supported and managed multiple critical quality and compliance projects across the US and Europe.

Dean has helped manage and deliver on key project initiatives in companies such as Bayer Diagnostics, Boston Scientific, Wyeth Pharmaceuticals, Pfizer, Sandoz, Fresenius Medical, GlaxoSmithKline and Johnson & Johnson. Some Projects include: technical transfers, consent decreed remediation, warning letter remediation, CAPA system implementation, critical project resource deployment and management, site set up, site closures, new product development and crises containment projects. Dean has 2 patents for a stent delivery device.

Dean holds a Bachelor of Technology in Electronics Manufacturing from University of Limerick, Ireland, has been PMP certified from The Project Management Institute and has a Master’s Degree in Business Administration from Liverpool St John Moore’s University, UK.

Karen Greene, CPP

VP of Client Solutions

Thanks to her extensive knowledge and experience in the medical packaging industry, Karen joined Network Partners as the Vice President of Client Solutions for Medical Device. Karen started her career in engineering management and packaging technology and has spent more than 20 years learning the ins and outs of the medical device industry. She’s served in several engineering and leadership roles with Edwards Lifesciences, Selzer Nutritional Technologies and Life Pack Labs.

Karen is an expert in terminally sterilized medical device packaging and ISO 11607, “Packaging for Terminally Sterilized Medical Devices, Part 1 and Part 2” and in temperature controlled packaging design, development and validation. She’s published many packaging publications and papers that have been included in Pharmaceutical and Medical Packaging News, Health Care Packaging and Packaging Digest. Karen earned a Bachelor of Administration in Biology from the College of the Holy Cross, a Bachelor of Science degree in Materials and Design Packaging I and II from Rutgers University and a Professional Certificate in Engineering Management from the University of California.

Dr. Jane E. Severin, PhD, MBA, CPP

VP of Technical Solutions

As Vice President of Technical Solutions, Jane brings a wealth of knowledge and a unique perspective to Network Partners. Jane started her distinguished career in medical device industry and has spent more than 25 years as a packaging professional. She’s served in several medical device and pharmaceutical roles with Baxter Healthcare, Bayer Corporation, Cardinal Health, Schering-Plough (Merck) Corporation, Oliver™ Healthcare Packaging, and Dupont Protection Solutions. Jane also founded two packaging consulting companies.

Jane holds a BS and a PhD in Packaging from Michigan State University and an MBA from Keller Graduate School of Management. In addition, Jane is an IoPP Certified Packaging Professional, Six-Sigma certified, holds two medical device patents and has been an instructor at Michigan State University’s School of Packaging, where she’s currently an adjunct faculty member. Jane was co-founder of the biannual Healthcare Immersion Event held by Michigan State University’s Medical School and School of Packaging.

Jane has published many packaging articles and papers for the likes of The Journal of Testing and Evaluation, Medical Device Manufacturing and Technology, Global Healthcare-Advanced Medical Technologies and the American Journal of Infection Control. In addition, she has delivered presentations and seminars at various conferences.

Ratinder Dhami, RAC

Director of Regulatory Affairs

As Director of Regulatory Affairs, Ratinder brings a wealth of knowledge and unique perspective to Network Partners. She has served in several medical device and pharmaceutical regulatory affairs roles with Abbott Neuromodulation (formerly St. Jude Medical), Cantox Health Sciences (now Intertek), Sanofi Pasteur, Dalton Pharma Services and Novopharm.

During her time at Abbott Neuromodulation, Ratinder served as the lead regulatory representative for new product development teams and CAPA teams. Her role included the development and implementation of regulatory strategies for Class III Premarket Approval (PMA) products, Class II 510k devices and EU Active Implantable Medical Devices. While at Cantox Health Sciences, she provided regulatory consulting services including preparation of regulatory applications such as INDs, IDEs, CTAs, NDS/NDA, ANDS/ANDA and PLAs for prescription drugs, biologics, over the counter drugs and natural health products.

At Network Partners, Ratinder leads a team of Regulatory Affairs professionals providing a range of regulatory affairs services to clients including regulatory strategy, submission authoring and regulatory project leadership to cross-functional teams. She is a RAC Certified regulatory affairs professional specializing in the pharmaceutical, medical device and combination products industries for key markets in the US, EU and Canada.

Elon Goldbaum

Director of Client Solutions

As Director of Client Solutions, Elon (Lon) brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling and the Apprentice program.

Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences and Danaher with a wide range of responsibility, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.

Chris Heckert

Director of Client Solutions | Labeling

Chris leads Network Partners Labeling Group helping Medical Device and Pharma companies bridge the gap wherever resources are needed to execute labeling projects. Chris started his medical device packaging career with DuPont, designing packaging and labeling for X-ray films. After the digital tide claimed the X-ray industry, he joined orthopedic giant Zimmer and spent 16 years in Packaging Development, eventually leading the group before joining Network Partners in 2016. In addition to deep hands-on knowledge of ISO 11607, Chris, a graduate of Michigan State University, led Zimmer’s efforts to deploy a Global Labeling System at their sites throughout the U.S and Europe, including a delayed, country specific labeling at their European Distribution Center.

Chris enjoys most craft beers and a good science fiction read. He’s married to the wonderful Shelly, has three adult children and is currently the guardian of two cats and a distinguished tank of freshwater fish.

Justin J. Kaler, MBA

Director of Client Solutions

As Director of Client Solutions, Justin brings over 10 years of marketing and sales experience in the medical device industry, most recently as the Global Marketing Leader for Foot & Ankle products at Zimmer Biomet. Justin has a strong background of developing sales programs and setting strategic direction to drive revenue.

As Director of Client solutions, Justin will continue to support and build on the client engagement momentum nationally and lead the university outreach effort promoting Network Partners’ Apprentice Leadership Programs.

Justin earned his Master of Business Administration from Indiana University. Justin and his wife, Rebecca, live in Fort Wayne, Indiana, and have three young boys, Noah, Eli and Titus.

Kylie Kehres, CPA

Controller

As Controller, Kylie manages the accounting and finance operations at Network Partners. She guides financial decisions and maximizes return on financial assets by establishing, monitoring and enforcing policies and reporting. Prior to joining the team, Kylie held a variety of roles within the medical device industry working in corporate finance, operations finance and product segment finance.

Kylie earned her BS in Finance and Accounting from Indiana University’s Kelley School of Business. She is a certified public accountant licensed in the state of Indiana.

Georgia C. Mohr

Director of Client Solutions

As Director of Sales & Marketing – Pharma, Georgia focuses on developing a strong business model and marketing campaign that resonates with pharmaceutical clients.  With over 25 years of wide ranging industry experience, including pharmaceutical packaging and adhesive technology, Georgia brings a unique combination of in-depth market and product knowledge as well as historical perspective on the pharmaceutical packaging industry.   She has held leadership roles for Bemis Healthcare Packaging, Alcoa/Reynolds, Dow Chemical (formerly Morton International) and Henkel (formerly Lord Corporation).  Georgia is a graduate of North Carolina State University where she earned a BS in Materials Engineering and she holds a Master Degree in Project Management from Western Carolina University

Aristotle Pantelis

Director of Client Solutions

As Director Sales & Marketing-Labeling, Aristotle supports all life science labeling teams by sharing information about Network Partners’ operational labeling services, contracted subject matter experts and consultancy for strategic initiatives. He brings customers over 20 years of holistic life science industry experience having provided solutions for refrigerated pharmaceutical logistic services, cGMP extended labeling manufacturing for Clinical Trials, Global Enterprise Labeling Lifecycle Technology and most recently Enterprise Translation Management Technology. 

Aristotle earned his BA from Florida State University and is a Veteran of the US Navy having served as a Russian linguist during the Gulf War.  Aristotle resides in Tampa, FL with his college-sweetheart wife, their Miniature Schnauzer and two great, adult kids nearby.

Harold Reisman, CPP

Director of Client Solutions

As Director of Client Solutions for Packaging Engineering, Harold helps organizations find the right packaging engineering expertise while contributing to the success of their strategic initiatives. Harold began his career in packaging design and development and has spent more than 20 years in the medical device industry. He’s served in many packaging and leadership roles with Boston Scientific, CR Bard and Bausch & Lomb.

Harold earned a BS in Packaging from Rochester Institute of Technology (RIT), an MA in Packaging from RIT and a BS in Psychology from Niagara University. Harold is a lifetime Certified Packaging Professional (CPP).

Angela Siebeneck, MSN, RN

Director of Medical Writing

As Director of Medical Writing, Angela leads the medical writing team and works with clients to determine the most efficient and effective way to manage their medical writing. She is an expert in European clinical requirements for EU MED DEV 2.7/1 Rev 4 , MDR and has executed gap assessments for new regulations. Her expertise expands across multiple devices and classes for Clinical Evaluation Reports (CERs). She has reviewed and authored over 50 CERs for multiple class devices to meet current guidelines. Angela has created clinical educational materials, SOPs, clinical protocols and worked on clinical studies. Angela also has experience with China and Australia’s clinical and CER requirements.

Angela served as the Associate Director of Medical Affairs and Medical Writing for Becton Dickenson Vascular Access Devices, formerly C.R. Bard, in Salt Lake City, Utah. During her time there, she reviewed risk assessments, IFU’s, performed health hazard evaluations, managed the speaker program and authored the 2016 C.R. Bard PICC Book: A Guide for Clinicians. Angela brings over twenty years of clinical expertise as a Registered Nurse specializing in interventional radiology, surgical intensive care, trauma, vascular access and wound care and her master’s thesis in interventional radiology.

Susan Speicher, MS, RAC

Director of Regulatory Affairs

As Director of Regulatory Affairs, Susan brings over 19 years of medical device industry knowledge across engineering, quality and regulatory affairs to the Network Partners team. Susan is a RAC Certified regulatory affairs professional specializing in the medical device products industry for key markets US, EU and Canada. Susan began her career as a medical device R&D Mechanical Engineer with Bayer HealthCare (formerly Medrad, Inc.) and has served in several regulatory affairs and quality systems management roles including with Bayer HealthCare, Omnyx, LLC (part of GE HealthCare) and PECA Labs.

During her time at Bayer HealthCare, Susan served as a lead regulatory representative for new product development teams, coordinating submission document development and implementation of regulatory strategies for Class II 510k devices. At Omnyx, Susan managed the Regulatory Affairs team and led the execution of regulatory strategies and submission document development for a Class II 510k device and a Class III Premarket Approval device. As Director of Quality and Regulatory Affairs at PECA Labs, she set-up the Quality Management System, securing the start-up company’s initial ISO 13485 quality certificate for the design and manufacturing of a Class II non-active pediatric implantable device.

At Network Partners, Susan leads a team of Regulatory Affairs professionals providing a range of regulatory affairs services to clients including regulatory strategy, submission authoring and regulatory project leads as part of cross-functional teams while supporting business development initiatives.
Susan holds a MS and BS in Mechanical Engineering from the University of Pittsburgh.

Tim Wech

Director of Program Management Solutions

Tim Wech has over 17 years of product development leadership experience and has successfully commercialized a wide range of class 2 disposable and class 3 active implantable products in the medical device industry.  A former PMO manager, Tim is a strong advocate for PM process standardization and the use of visualization tools to clearly communicate project information throughout an organization.  As a facilitator and coach, he excels at helping widely distributed teams collaboratively create robust project plans and effective risk management strategies to start strong and stay on the right track throughout the development lifecycle.  Tim holds an MS in Construction Engineering and Management from the University of Michigan, a BS in Marine Engineering from the United States Coast Guard Academy, and is a licensed Professional Mechanical Engineer.

Nicholas Werner

Director of Regulatory Policy & Education

As Director of Regulatory Policy & Education, Nicholas brings over 11 years of diverse experience in the medical device industry to Network Partners. Nicholas began his career as a premarket reviewer for the US Food and Drug Administration and has also served in a TPLC Regulatory Affairs role with Stryker Instruments.

During his time at the Agency, he worked with various device types and shifted between premarket and postmarket analysis of medical devices. His role included the review of numerous submission types, including 510(k)s, PMAs, IDEs, 513(g)s, and pre-submissions. From a postmarket perspective, Nicholas served as an analyst for adverse events and worked to help establish and implement CDRH’s Signal Management Program. At Stryker, Nicholas served as the Regulatory Technical Lead for the Interventional Spine Business Unit and composed numerous regulatory submissions for both the US and the EU. Additionally, he took on policy and advocacy work, including interfacing with AdvaMed and internal Government Affairs partners.

At Network Partners, Nicholas develops, advocates for and implements company positions on regulatory policies that impact clients. He also develops and delivers internal and external educational offerings on various regulatory topics and is the head of the Regulatory Affairs Apprentice Program.
Nicholas holds a BS in Bioengineering from the University of Pittsburgh.