About Our Team

F. David Rothkopf
President and Founder

F. David Rothkopf has 35 years of professional strategic experience in the development and regulatory control of medical devices. He is the President and Founding Principal at MEDIcept Inc., established in 1996, offering innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries. His expertise includes technical and hands-on knowledge in a variety of regulatory, compliance management, and quality process. He has performed over 400 ISO 13485 and FDA-style audits in the past 20 years. David has submitted over sixty-five 510ks and PMAs. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Software Validation, Risk Management, and Hazard Mitigation throughout a product life cycle.

As the President and Managing Partner at MEDIcept, David is responsible to set vision, mission, policies and the short- and long-term strategic direction for the corporation. This includes ensuring the corporation, its officers, and employees follow the mission, policies and procedures that are in place. He oversees all the financials aspects of the company and maintains awareness of both external and internal opportunities for expansion, customers, markets, new industry developments and standards.

David is an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a mentor for MassChallenge Accelerator, MIT Idea² program and NIH's NHLBI Catalyze Program, and now advises Doctoral students at Johns Hopkins Whiting School of Engineering on Regulatory Affairs and undergraduates at the University of Texas, Dallas and Worcester Polytechnic Institute. He is also the President of SON Medical, a shareholder advisor for two device companies and a partner in two orthopaedic device companies. Before joining MEDIcept, he was the Chief of Operations and co-Founder of Zmed and Chief of Operations and co-Founder of Mrad and was instrumental in their sale. He was the Director of Quality at Uromed and a Project Leader at Johnson and Johnson Professional.

David holds a B.S and M.S degree in Mechanical Engineering from Worcester Polytechnic Institute. He also holds an MBA from Boston University. He is a member of RAPS, ASQ, ASQ Biomedical, and ASME. He is an advisor for a Special Needs School and a non-for-profit school.

Brian Markham
Managing Director and Vice President, Special Projects

Brian has over 30 years of medical device and quality management systems experience. He is a seasoned FDA and ISO 13485 auditor and provides audit readiness training and consultation for his clients. His expertise includes providing quality leadership for organizations undergoing significant quality system changes due to regulatory concerns, remediation, acquisition, or growth. His career began as a bench chemist developing diagnostic ELISA kits. Career experience was gained through product support, development, facility compliance, and corporate level quality assurance roles.

As VP Special Projects, Brian is responsible for managing quality systems support endeavors and special projects. This includes overseeing quality system implementation, quality system training, gap assessments, auditing, audit readiness, responses to regulatory findings/actions, and remediation activities.

Prior to merging with MEDIcept in 2020, he owned and operated Quality Systems in Motion, Inc. (QSIM), providing expert consultation resources to medical device, biotech, and pharmaceutical organizations facing challenging compliance concerns. Brian has served in quality leadership positions at both small and large organizations, including Bayer, Boston Scientific and Abbott Bioresearch.

He holds a bachelor’s degree in Chemistry from Virginia Tech and an associate’s degree in Mathematics from Bergen Community College.

Jason Gromek
Executive Vice President, Sales and Operations

Jason Gromek has over 20 years of medical device design, quality systems, quality engineering and regulatory compliance experience. Jason has been a leader and contributor of implementation and compliance activities for 21 CFR 820 and ISO 13485 compliant Quality Management Systems and has been responsible for Product Development Lifecyle activities and U.S. and EU regulatory guidance.

As Executive Vice President, Sales and Operations, Jason leads our Sales, Quality, Regulatory and Clinical teams for MEDIcept. He is positioned to establish and communicate the strategic direction of company operations. Jason works closely with MEDIcept service line managers to ensure we are constantly cultivating strong, long-term relations with our customers and partners. This includes promoting a positive MEDIcept culture throughout the organization and advancing MEDIcept Business objectives.

Jason has held various management roles, both as a consultant and in industry. Before joining MEDIcept, Jason was Founder and President of BioDevice Design, LLC, a medical device development company. BioDevice was a founding member organization of America Makes – National Additive Manufacturing Innovation Institute which was established to promote 3d printing in manufacturing.

He was Director of Engineering and Development at Meditech Spine and worked as a medical device design consultant for O’Savage Biomechanics. While at Meditech, Jason led the initiative to obtain regulatory clearance for Hydroxy appetite PEEK; at the time only the second company in the world to obtain clearance. Jason holds many patents in the areas of spinal implants.

Mr. Gromek is a member of ASQ and is a Certified Biomedical Auditor and Certified Quality Auditor.

Bob Silva
Senior Director, Software Quality Engineering

Bob Silva has extensive experience with domestic and international medical device development as an engineering executive having managed collaborative engineering teams designed to effectively create customer focused solutions. His background in medical device design and development started in software and expanded over the years to provide full engineering expertise in all aspects of medical device design and development. This includes full product life cycle development from concept through design and into product manufacturing working in startup environments as well as large corporate entities. He is a strategic thinker with the engineering leadership skills and experience in product and software lifecycle development that has resulted in approved product continuing to be used in the field today.

As the Senior Director of the Software Quality Engineering team at MEDIcept, Bob is responsible for ensuring that day-to-day operations of the software QE department work collaboratively with other departments in MEDIcept, ensuring compliance related to software design and development on the various client and MEDIcept projects. This includes successfully planning and managing multiple, parallel projects to successful completion on time and within budget and to the satisfaction of MEDIcept customers.

Before joining MEDIcept, Bob held various leadership positions at companies like Draeger Medical System, KMC Systems, FluidNet/Ivenix, Infraredx and Transfusion Technologies / Haemonetics. Early in his career he was responsible for the design and development of medical device software for some of these companies resulting in product still being used in industry today. He also has experience with in the late ‘80s and early ‘90s with Symbiotics, Inc. where, as a founder, he was responsible for helping acquire venture backed funding to drive the development of an object-oriented middleware solution used to connect computers of different types together that ultimately was embedded within IBMs OS-2 operating system.

Bob holds both a B.S. and M.S. degree in Computer Science from Northeastern University.

Stephen Gilbert
Senior Consultant, Quality Engineering

Stephen Gilbert has over 30 years of experience in the medical device industry (orthopedics, radiation therapy, intraoperative x-ray, and laser therapy). His main areas of expertise are in the Product Development process and Project Management within the regulatory requirements of QS Reg, MDD, MDR, IVDD, IVDR, ISO 13485, and GxP.

As a Senior Design Quality Engineer, Stephen is responsible for aiding clients with Design Control processes including defining Requirements Specifications, Risk Management, Verification and Validation, Usability, Design Transfer and DHF compilation.

Before joining MEDIcept, he was a consultant partner for Wipro, where his main efforts were in helping companies meet MDR requirements. This included performing gap analyses and remediation of QMS and product Design History Files for domestic and international clients. He also held positions in Product Development at Stryker, Depuy-Synthes, and Zimmer. Stephen has extensive experience in design control, risk management, CAPA, complaint handling, change management, and product verification and validation, including fatigue testing, fracture analysis, FEA, cadaver sessions, competitive benchmarking, and reverse engineering. He has authored or contributed to 510(k) submissions, PMAs, PMA supplements, and IDE submissions for sterile and non-sterile Class ll and Class lll devices. Stephen also served as point contact for FDA and NB design control audits of Design History Files.

Stephen holds a Bachelors and Masters degree in Mechanical Engineering from the University of Ottawa. He has led international teams from the US and Europe, working extensively with surgeon KOL’s to identify clinical needs and develop implant and instrument systems to meet those needs. He has authored or co-authored numerous peer reviewed articles, patents, and white papers. Stephen lived and worked in Switzerland for two years and is conversant in English, French, and German.

Trevor Klemann
Associate Consultant

Trevor Klemann has worked on several projects to develop experience within Quality Management Systems, including working with ISO 14971 in the risk management process and EU MDR updates for multiple devices.

As a participant in the Leadership Immersion Program, Trevor serves MEDIcept as an Associate Consultant. Trevor is training in medical device Regulatory, Quality, and Clinical Affairs. This includes completion of a training rotation in each consulting service area, studying and contributing to client projects under the leadership of SMEs.

Before joining MEDIcept, he worked as a Product Development intern for Novocure, where he worked closely with quality engineers to improve efficiency in the risk management process for tumor treating field medical devices.

Trevor holds a Bachelor of Science degree in Biomedical Engineering with a concentration in Biochemistry from The Pennsylvania State University.

Kristina Poberezhnaya
Associate Consultant, Quality Engineering

Kristina Poberezhnaya has three years of experience involving prototype building within Quality Management Systems. This includes working with ISO 13485, FDA 21 CFR 820.30 Design Controls, CAPA management, FDA 510k, ISO 14971 in Risk Management, and developing a Design History File for each project.

Kristina has recently joined the Quality Engineering team as an Associate Consultant, where she assists with developing and managing Software Quality Engineering Systems to meet FDA QSR, ISO 13485, IEC 62304, ISO 14971, ISO 62366, and other applicable regulatory requirements. Her role includes the planning and execution of non-product software implementation and validation projects including working with clients on supplier and IEC 62304 audits related to software. Kristina assists with corrective action strategy and development related to Supplier Quality Management activities and works on development to deliver customized client training and education programs related to Software Quality Engineering activities.

She has recently graduated from the MEDIcept Leadership Immersion program, where she received in-depth training and hands-on experience in Quality, Regulatory, and Clinical Affairs.

Kristina graduated from Wayne State University with a Bachelor of Science in Biomedical Engineering and a concentration in Biomechanics as a first-generation student. She is looking forward to continuing her growth in her experiences with MEDIcept.

Brian Siroka
Associate Consultant

Brian Siroka has an aptitude for product development, design implementation, and validation. He designed and commissioned several advanced bottle handling systems in his previous role. Brian has also facilitated MHRA audit responses and performed validation of sterilization systems. Apart from his traditional knowledge, Brian holds competencies in machining, wire routing, and thermal-fluidic experimental testbed construction. He has a friendly and caring attitude, a hardworking mentality, and a passion for the field.

As a participant in the Leadership Immersion Program, Brian serves MEDIcept as an Associate Consultant. Brian is training in medical device Regulatory, Quality, and Clinical Affairs. This includes completion of a training rotation in each consulting service area, studying and contributing to client projects under the leadership of SMEs.

Before joining MEDIcept, he worked as a Mechanical Design Engineer at Dyco, Inc. In this position, he was responsible for designing and implementing plastic bottle handling machinery. He translated client information from the sales team into actionable engineering criteria.

Brian holds a dual B.S. degree in Mechanical Engineering and Biomedical Engineering from The Pennsylvania State University. At Penn State, he was a dedicated tour guide and THON Captain, an organization that raises money for pediatric cancer.

Carolyn Russell
Director, Quality Systems

Carolyn Russell has over 25 years of experience in the medical device and manufacturing industry. Although her focused area of expertise includes Quality and Compliance Management, QMS harmonization, remediation efforts, risk management, supplier management, CAPA, training, and document and change management, she has broad experience and in-depth knowledge of FDA and ISO requirements pertaining to product development, risk management, and post-market activities. In addition, she has assisted clients with Adverse Event reporting, annual reporting, UDI submissions, and FDA facility and device registrations.

As a Quality Management Systems Manager at MEDIcept, Carolyn is responsible for managing the Quality Systems department, including managing clients, assigning responsibilities, and monitoring the department's progress. Additional roles include serving as a project manager, supporting the development and management of Quality Management Systems, such as design control systems, risk management, CAPA, complaint handling, supplier management, production control, and management responsibility to meet applicable regulations. In addition, she performs internal audits, gap assessments, supplier audits, assists clients with FDA investigations and ISO assessments, and delivers customized client training and education programs.

Before joining MEDIcept, she worked as a compliance leader in the medical device and manufacturing industry (SaMD, radiology, aesthetic lasers, and cardiac devices). This includes serving as Director of Quality, Senior Manager of Quality and Compliance, and Senior Quality Manager, including designation as Management Representative and US Agent for foreign business units.

Carolyn holds a B.S. degree in Business Studies, Industrial Organizational Psychology from Southern New Hampshire University. She’s a member of the American Society for Quality (ASQ) and Regulatory Affairs Professional Society (RAPS). Carolyn is a Certified Quality Auditor through ASQ and holds a Regulatory Affairs Certificate: Medical Devices through RAPS, Lead ISO 13485 Auditor Certificate, and EU MDR Auditor Certificate.

Catherine Crismon
Sr. Quality Systems Consultant

Catherine Crismon has over 25 years of experience in Quality and over 10 years in the medical device industry. Although her focused area of expertise is in internal audits, she also has experience in Risk Management and Process Improvement, as well as extensive experience in QMS development and implementation. Her certifications include Lead Auditor to the EU MDR, MDSAP, and ISO 13485. She has experience with CAPA and Complaint program development, document management systems, and training. In addition, to performing numerous Medical Device Quality Management System audits she has assisted many clients in developing compliant Quality Management Systems.

As the Sr. Quality Systems Consultant at MEDIcept, Catherine is responsible for successfully developing and managing Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP and other applicable regulatory requirements. This includes conducting/leading/ assisting clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.

Before joining MEDIcept, Catherine worked as an internal auditor for Wright Medical / Stryker and as an independent consultant for various consulting organizations. Throughout her career, Catherine has held various management positions in Distribution, Purchasing, and Quality.

Catherine holds a B.S. degree in Business Administration from Columbia College in Columbia, MO and a MS degree in Human Resources from Lindenwood University in St. Charles, MO. She is a member of ASQ and the ASQ Audit Division. She has also held various community volunteer positions and is a former advisory board member at the YMCA.

Ryan Satterly
Sr. Quality Management Systems Consultant

has over 15 years of medical device R&D, quality system, quality engineering, and regulatory compliance experience. He has successfully designed and implemented quality management systems and regulatory approaches for companies, which have been reviewed and accepted by global regulatory agencies. He has performed many Quality Management System audits and has educated numerous medical device companies on US and international standards. His areas of expertise include all aspects of QMS remediation, QMS development and implementation, CAPA programs, document management systems, and integration of risk management and cybersecurity throughout the product development lifecycle.

As a Senior Consultant, Ryan is responsible for providing proven solutions in quality systems, quality engineering, regulatory affairs, risk management, human factors, cybersecurity, and clinical trials. This includes developing and implanting design controls, design change management, customer complaint programs, non-conformance and CAPA management, and associated training programs.

Before joining MEDIcept in 2023, Ryan served in Quality & Regulatory leadership roles at medical device and biotechnology companies, as well as organizations which provide products and services to the medical device and biotechnology industries. He has successfully led the submission and approval of two 510(k) packages, including pre-submission meetings, review & creation and submission and has held positions as primary contact for regulatory inspections and inquiries.

Ryan achieved the certification for CQI and IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP requirements, issued by NSF in November 2023.

Ryan holds a master’s degree in engineering management from Case Western Reserve University. He is a member of Regulatory Affairs Professional Society (RAPS).

Calia Van Zyl
Associate Consultant, Quality Systems

Calia Van Zyl has over six years of experience within the biotechnology industry which has allowed her to develop skills in quality and regulatory affairs in a breadth of laboratory environments. Her background is in production, research, and clinical settings. Calia’s skill set includes knowledge of the ISO 13485:2016 standard, FDA 21 CFR experience, as well as CLIA/CAP regulations.

As an Associate Consultant within the Quality Systems team at MEDIcept, Calia is responsible for developing and managing our client’s compliant Quality Management Systems (QMS). This includes development and implementation of CAPA, nonconformance and complaint programs, document management systems, and associated training programs. Additionally, she will assist clients with audits and remediation tasks.

Calia’s career began in a Research Cells production laboratory where she supported the laboratory’s quality compliance through actionable Good Laboratory Practices, as well as via Device History Record and SOP improvement initiatives. She next took on the role of GMP Process Development manager at an Oncology research institution, working on the scientific development of novel cellular cancer immunotherapy. During her position managing a Clinical Immunology Laboratory, Calia introduced a newly developed flow cytometry-based LDT and prepared the lab for CLIA/CAP inspection readiness.

Calia graduated from North Carolina State University with a Bachelor of Science in Cellular, Molecular, and Developmental Biology and a Minor in Biotechnology.

Melissa Paffenroth
Senior Consultant, Regulatory

Melissa is a forward-thinking professional with 11+ years of success in regulatory affairs and 5+ years of success in research and development. She is experienced in medical devices and IVD medical devices.

As a Senior Regulatory Consultant, Melissa is an integral part of the MEDIcept team. She leverages her technical skill set into in her regulatory work.

Before joining MEDIcept, she was the Regulatory Manager at ZOLL Medical and ACE Surgical Supply Co., Inc., a subsidiary of Henry Schein. She also held regulatory positions at Waters Corporation and Smith & Nephew in the Endoscopy Division.

She holds a Doctorate of Science in Biomedical Engineering and Biotechnology, Master of Science in Biomedical Engineering and Biotechnology and Bachelor of Science in Plastics Engineering from The University of Massachusetts Lowell.

Natalie Vollrath
Senior Consultant, Regulatory

Natalie Vollrath brings over 30 years of experience as a quality and regulatory professional in the medical device industry. She has broad experience across multiple product categories and device classes, preparing regulatory submissions and obtaining product registrations for U.S and international markets. Natalie has led ISO and FDA regulatory and compliance efforts throughout the product lifecycle and played a key role in new product introductions.

As a Sr. Regulatory Consultant at MEDIcept, Natalie assists clients with their regulatory needs, including determination of the regulatory pathways for US, EU, and other international markets, developing and preparing submissions, technical files, Pre-Submission meeting requests, non-filing justifications, and other regulatory documentation and activities.

Before joining MEDIcept, she held roles including Quality Assurance/Regulatory Affairs Manager at various companies in the medical device industry, working with a diverse range of products that included Software as a Medical Device (SaMD) and Software as a Service (SaaS).

Natalie holds a B.A degree from the University of California, San Diego as well as certificates in Systems Engineering and Biostatistics. She is Regulatory Affairs Certified through the Regulatory Affairs Professionals Society (RAPS). Natalie also holds several additional certifications through ASQ, including Certified Medical Device Auditor, Certified Quality Engineer, and Certified Software Quality Engineer.

Ericha Flateau
Senior Project Manager

Ericha has over 10 years of experience leading and managing complex Medical Device and Med Tech projects and programs. Ericha is passionate about proactive communication and bringing teams together to effectively collaborate for the best chances of success. She prides herself on being a team leader and mentor.

As a Senior Project Manager, Ericha plays a pivotal role in guiding teams of internal consultants, contractors, and client team members through various stages of remediation, product development, and regulatory processes. She ensures successful and timely delivery of projects within budget and in compliance with the rigorous medical device regulations.

Before joining MEDIcept, she led multiple Medical Affairs and Clinical Operations teams through remediation projects to ensure their documentation fit the requirements of the changes in regulations. In addition to guiding teams to deliver these projects on time and on target, Ericha also helped to build out shared services groups and strategic arms to Project Management Organizations to better support both internal company infrastructures and client success. Most recently, Ericha worked to define clearer processes and procedures for an R&D team working to bring new medical devices to clinical trials and eventually to market.

Ericha has a Bachelor’s degree in Biology from Rhode Island College and has successfully completed advanced project management workshops led by ProChain Project Solutions. Ericha is currently pursuing her Project Management Professional (PMP) Certification.

Danielle Short
Associate Consultant

Danielle has experience leading and managing project engineering workshops focused on foundational engineering skills both in-person and using various online platforms.

Danielle joins the team at MEDIcept and is growing her knowledge of the medical device and consulting industry. She brings her background in Biomedical Engineering and leadership and teamwork skills to the Leadership Immersion program.

As a participant in the Leadership Immersion Program, Danielle serves MEDIcept as an Associate Consultant. She is training in medical device Regulatory, Quality, and Clinical Affairs. This includes completing a training rotation in each consulting service area and contributing to client projects under the leadership of SMEs.

Before joining MEDIcept, Danielle attended the University of Delaware, graduating in May of 2022 with a Bachelor of Biomedical Engineering. While at the University of Delaware, Danielle worked on a wide variety of engineering projects in the Biomedical Engineering department and served as an undergraduate teaching assistant.

Kristin Hunt
CRA Field Monitor

Kristin has over 13 years of experience in the clinical research industry as a Study Coordinator, Regulatory/Start Up Specialist, and Clinical Research Associate. She has worked extensively on both device and all phases of pharmaceutical trials.

Her experience spans over five years of on-site experience as a Study Coordinator and In-House Monitor, eight years at various CROs in Study Start Up/Regulatory Services, and most recently as a Clinical Research Associate. As a Coordinator and Internal Monitor, she worked on several neurology and pediatric psychiatry trials and an oncology registry project.

As Field CRA Monitor at MEDIcept, Kristin is responsible for monitoring all trials both remotely and on-site and ensuring adherence to Good Clinical Practices, data accuracy, investigator integrity, and compliance with all study procedures.

Kristin holds a B.A. in Psychology from University at Buffalo, State University of New York.

Sarah Boynton
Associate Consultant

Sarah has experience in various team-based projects within engineering and beyond. She is looking forward to expanding her knowledge and skills at MEDIcept.

As a participant in the Leadership Immersion Program, Sarah serves MEDIcept as an Associate Consultant. She is training in medical device Regulatory, Quality, Clinical Affairs, and Sales. This includes completing a training rotation in each consulting service area and contributing to client projects under the leadership of SMEs.

Before joining MEDIcept, Sarah worked for a Sponsored Programs Office. In this role, she entered data into a record management system, worked on continuous development of document workflows, and ran quality control reports.

Sarah holds a Bachelor of Science in Biomedical Engineering and Psychology Minor from Worcester Polytechnic Institute. At WPI, she held several leadership positions, planning and executing multiple large-scale events.

Abby Rieck
Associate Consultant

Abby Rieck has cultivated a passion for medical device development through her previous intern experiences managing engineering projects for start-up medical device companies. As a member of the MEDIcept team, Abby continues to expand her knowledge and experience in the medical device and consulting industries.

As an Associate Consultant in MEDIcept’s Leadership Immersion Program, Abby is undertaking comprehensive training in Quality Management, Regulatory, and Clinical Affairs. This includes completion of a training rotation in each consulting service and contributing to client projects under the mentorship of subject matter experts.

Prior to joining MEDIcept, Abby completed internships with Contraline, Inc. and Embark LLC. She also held an internship position with Merge Medical Device Studio, where she contributed to the assembly of deliverable prototypes for fifteen novel medical device projects.

Abby holds a B.S. degree in Biomedical Engineering with a minor in Engineering Business from the University of Virginia.

Emily Sawtell
Associate Consultant

Emily has experience working on teams focused on the optimization of medical devices. She also has experience leading and managing cross functional teams.

Emily is an Associate Consultant at MEDIcept, participating in the Leadership Immersion Program, where she will complete rotations to train in medical device Quality, Regulatory, and Clinical Affairs. This will allow her to learn more about each sector of medical device consulting. Emily will get to apply her knowledge to projects in the different departments at MEDIcept.

Before joining MEDIcept, Emily held the position of Supply Chain Logistics Captain at Penn State THON where she coordinated with five committees to ensure that each of their events throughout the year had the correct supplies. She worked on an Inventory Team to maintain several storage spaces that housed all of THON's supplies and collaborated with donor contacts to ensure all necessary supplies for preTHON events and THON Weekend were donated. This resulted in $130K cost savings for the organization. Emily was also the Logistics Officer at Penn State Homecoming where she oversaw the Logistics Directors and committee members coordinating the planning and execution of eight major events throughout the year.

Emily holds a B.S. in both Biomedical and Mechanical Engineering from Pennsylvania State University.
Before joining MEDIcept, Danielle attended the University of Delaware, graduating in May of 2022 with a Bachelor of Biomedical Engineering. While at the University of Delaware, Danielle worked on a wide variety of engineering projects in the Biomedical Engineering department and served as an undergraduate teaching assistant.

CJ Stukel
Associate Consultant

CJ’s interest in medical devices came from working on design and development teams for two medical devices that are currently patent pending. The knowledge of D&D process will be useful while working with clients to get their devices to market.

CJ is joining the team as an Associate Medical Device Consultant through the Leadership Immersion program. He will be rotating through the Clinical Affairs, Quality, Regulatory, and Sales team to learn and gain hands-on experience before taking on a permanent role.

Before joining MEDIcept, he worked at 3M’s main medical device plant in Brookings, SD. The experience on the floor showed him how important quality and regulatory engineering are to getting a product to market. CJ also served as the president for the SDSU chapter of the Biomedical Engineering Society. This experience helped develop his leadership skills while also providing knowledge about the field from multiple speakers.

CJ holds a Bachelor of Science degree in Mechanical Engineering and a Biomedical Engineering Minor from South Dakota State University. He is excited to continue learning while helping clients of MEDIcept.

Sarah holds a Bachelor of Science in Biomedical Engineering and Psychology Minor from Worcester Polytechnic Institute. At WPI, she held several leadership positions, planning and executing multiple large-scale events.

John Zawacki
Vice President of Commercialization

John Zawacki has over 30 years of experience in the medical device industry, leading teams commercializing products and services. He has led the development of 20 medical device products and services from within a variety of functional roles, including product development, market development, and business development. In his over 8 years in business development roles, he has sold a variety of offerings, including contract manufacturing, drug packaging, temporary staffing, and consulting services.

As Vice President of Commercialization at MEDIcept, John leads the business development team, nurturing client relationships and introducing new prospects, while working closely with service line leads and strategic partners to ensure a positive customer experience.

Before joining MEDIcept in 2023, he was Vice President of Business Development for regulatory and quality consultancy RQM+. He has also held leadership positions at standard development organization CSA Group, UMARVL consultancy, Aptar Pharma, Teleflex Medical, r4 Vascular, American Medical Systems (now Boston Scientific), and C.R. Bard (now Becton Dickinson).

John holds a B.A.Sc. degree in Mechanical Engineering from the University of Toronto. He’s an advisor for Minnesota State University’s Customer Experience Certificate Program, and a member of both RAPS and medical sales executive group SMMG. He holds multiple patents, has been a speaker at Medical Design & Manufacturing trade shows, and has contributed articles to Business Briefing, and the Canadian Journal of Anesthesia.

Mandy Lantigua
Senior Manager, Contracts and Proposals

Mandy Lantigua has over 20 years of experience in the contracts and legal field. Although her focused area of expertise includes contract management, negotiation and dispute resolution, she also has extensive experience in proposal writing and submission of high-quality RFP responses. In addition, she has many years of experience developing and creating engaging marketing materials.

As the Senior Manager, Contracts and Proposals at MEDIcept, Mandy is responsible for supporting requests for accounts, opportunity, reports and contract maintenance in Salesforce, generating client facing contracts and making improvements as needed, supporting the Marketing Department with Pardot tracking.

Before joining MEDIcept, she worked as the Director of Commercialization managing contracts and developing winning proposals. Throughout her career, Mandy has held various positions relating to contract and proposal management, contract dispute as well as general legal matters.

Mandy graduated from Florida State University.

Robert Pepper
Head of Marketing

Rob Pepper is a marketing executive, revenue growth strategist, and business transformational leader in the small to mid-size emerging healthcare services markets. His accomplishments have been nationally recognized. He is the recipient of numerous multi-industry and leadership awards for his contributions in accelerating growth for innovative companies.

As the Head of Marketing at MEDIcept, Rob oversees the development and implementation of strategic marketing plans to promote products or services effectively. He analyzes market trends, consumer behavior, and competitor strategies to drive brand awareness and maximize revenue. Additionally, Rob collaborates with cross-functional teams to ensure alignment between marketing efforts and overall business objectives.

Rob is known as a visionary sales, marketing, and financial strategist as well as motivational leader who builds strong internal teams and partnerships to consistently deliver exceptional results. Rob’s contributions have been instrumental in growing several ventures including four being acquired by Fortune 500 companies. Prior to joining MEDICept, Rob served as the Vice President, Global Marketing for regulatory and quality consulting firm RQM+. Prior roles include senior leadership positions in marketing, client services, business development and consulting services with 3M Health, VISICU, Philips and Hillrom/Baxter. Building and managing high-growth sales, marketing and product organizations that deliver extraordinary growth is Rob’s passion and expertise. CEOs of public and private emerging and mature B2B services and technology companies have recruited Rob to provide high performance leadership and direction to support growth and market expansion.

Selective Awards:

• SmartCEO Magazine – Marketing Executive Leadership Award
• KLAS: Numerous #1 Best in KLAS awards for Records Documentation solutions

Ava Carr
Content Creator

Ava has over 3 years of experience working in marketing and content creation. She has a passion for the life science industry and her degree in Integrated Science and Technology has equipped her with a strong foundation in problem-solving, technical knowledge, and excellent collaboration, teamwork, and research skills. She is eager to contribute her knowledge and skills to MEDIcept and make a meaningful impact in the life science industry.
As the Content Creator at MEDIcept Inc., Ava is responsible for creating content for MEDIcept's communication and marketing strategy to position it as the leader in the Medical Device Consulting Services industry, as well as managing and developing various communication and marketing materials. Ava is also responsible for analyzing complex technical topics, communicating with stakeholders, and sending emails through mass communication tools.

Before joining MEDIcept, she worked as an intern for the Biotechnology Innovation Organization where she was responsible for data analysis, marketing deliverables, and supply chain research. Ava has additionally built a community of over 30,000 across Instagram and TikTok where she leverages her audience to increase consumer awareness, knowledge, liking and/or purchase of a brand or product. She has collaborated and created relationships with brands such as Aeropostale, Steve Madden, Saucony, Nexxus and more.

Ava earned her B.S. degree in Integrated Science and Technology, specializing in Biomanufacturing, with a minor in Global Supply Chain Management from James Madison University. She graduated Magna Cum Laude and earned the “Integrated Science and Technology Capstone Integration Award” for efficiently and effectively integrating several areas of expertise in her senior capstone project titled “The COVID-19 Vaccine Supply Chain in the United States”.

Chloe Thomas
Marketing & Communications Coordinator

Chloe Thomas has over five years of experience in the marketing and communications industry. Although her area of expertise includes social media content creation and multimedia marketing, she has a broad experience in product promotion, organizational promotion, journalism, graphic design, and many other marketing and communication skills.

As the Marketing Communications Coordinator at MEDIcept, Chloe is responsible for creating and editing presentation material, designing website content, managing social media, and budgeting for promotions. Chloe will also be responsible for establishing and maintaining relationships with various teams and vendors, and working on an annual marketing plan.

Before joining MEDIcept, she worked as a Social Media Coordinator for Neat Companies. Throughout her career, Chloe has held various positions such as Social Media Coordinator, Marketing Manager, Public Relations Assistant, Admissions Assistant, and more.

Chloe holds a B.A. degree in Communication and Journalism from Lindsey Wilson College. Throughout her time at Lindsey, she was a Student Ambassador, Peer Mentor, International Student Program Ambassador and Host Family, Student Government Representative, and employed in both the Public Relations and Admissions offices. She was awarded the “Outstanding Achievement in Media Studies and Journalism” award for two consecutive years and the “Outstanding Achievement in Communication” award. Chloe has also held various community and charity volunteer positions.

Michelle Walsh
Office Manager

Michelle Walsh has over 25 years of experience in office administration.

As the Office Manager at MEDIcept, Michelle oversees the daily administrative functions and serves as a liaison to the executive team, human resources, and accounting. She is also the point of contact for clients.

Before joining MEDIcept, she worked as an office administrator for a family-owned IT consulting company. While working there, Michelle was responsible for general office functions including bookkeeping, developing marketing campaigns, event planning, business development, and customer service. Throughout her career, Michelle has held various positions such as market research manager in the hi-tech industry; facilities manager and executive assistant for an engineering and environmental company; and property manager for commercial and condominium properties throughout Massachusetts. She also holds a real estate salesperson license in Massachusetts.

Michelle has a B.S. degree in Business Administration with a Minor in International Business from Framingham State University. She has also held various community volunteer positions including serving on the Board of Directors for the Blackstone River Watershed Association, an advocacy group for the Blackstone River.

Nick Radoux
Manager, Talent Acquisition

Nick Radoux is a Recruitment / Talent Acquisition Specialist within the Life Science industry. Nick has sourced consultants across the Americas for Quality Assurance & Regulatory Affairs. Nick has successfully sourced consultants to support projects such as remediation efforts following FDA 483’s & Consent Decrees, QMS implementations, Audits, Investigations, Regulatory Submissions, Interim management support, design quality, and CQV activities.

As the Talent Acquisition Manager, Nick is responsible for overseeing the recruitment activities at MEDIcept. Working directly with Senior Executives and HR, Nick will support the rapid growth of MEDIcept by finding talented industry professionals who will grow with MEDIcept and continue providing trusted solutions for their vast global client base.

Before joining MEDIcept, Nick worked as a recruitment specialist for a large global staffing company. Nick built a contract recruitment desk from the ground up and generated revenues exceeding $500k. Nick acquired deep industry knowledge and an extensive network of consultants, which resulted in over 20 active consultants performing work on behalf of the company.

Nick holds a B.S. degree in Business Studies from Canterbury Christ Church University. Project Management certification, management qualifications from previous employers, and multiple sales awards/achievements.