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Chris Chapman is listed as Medical Device Development Expert | Technical Compliance | Program Manager | MSBME, MBA, PMP at Chapman Collaborative LLC, based in Gainesville, Florida, United States. AeroLeads shows a work email signal at exac.com, phone signal with area code 352, and a matched LinkedIn profile for Chris Chapman.
Chris Chapman previously worked as Owner, Consultant at Chapman Collaborative Llc and Director E&D | Core Engineering at Exactech. Chris Chapman holds Master Of Business Administration (Mba), Management from University Of Florida - Warrington College Of Business.
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I help companies effectively balance business and compliance needs through leadership of teams and technical programs in new product development, design assurance, and regulatory operations, with a focus on data and process integrity. As a systems thinker, I have successfully integrated disparate elements of business and development processes at all organizational levels, including the establishment of enterprise PMO foundations that align highest-level strategic initiatives with day-to-day project execution. I excel at navigating complexity and uncertainty in cross-functional environments by fostering strategic relationships, identifying unmet needs, and helping teams deliver innovative solutions to develop and launch great products. Building on an extensive early career focused on engineering design and development, design controls, and risk management, I have since created, directed, and expanded an enterprise program for development of FDA class II surgeon- specific instrumentation for the hip, knee, shoulder, and ankle. I have also led and implemented large scale regulatory compliance initiatives in several areas including UDI/GUDID, EUDAMED, and 2D data matrix direct part marking.
Listed skills include Biomedical Engineering, Medical Devices, Design Control, Biomaterials, and 34 others.
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Gainesville, Florida, United States
Focus areas:• Technology transfers• Regulatory Operations• Business Processes and workflows (Smartsheet/Control Center)• Design Control/Remediation
Gainesville, Florida, United States
• Scale-up and continuous improvement of surgeon specialty instrument program, completing over 200 launches• Established enterprise-wide program and portfolio management process using SmartSheet Control Center, integrating 175 cross-departmental projects and top-level corporate initiatives• Implemented tiered RAID escalation process resulting in substantial increase in communication and decision-making of high priority issues at executive team level• Leadership of and growth of technical managers, engineers, designers, drafters, machinists, and technicians in a mixed remote/onsite environment• Performed program oversight and administrative activities including project spin-up, data consistency, monitoring, archiving, on-boarding, training, license allocation, and blueprint updates• Internal subject matter expert for requirements gathering, build-out and implementation of streamlined functional area and cross-functional workflows and business processes (RA, QA, OPS, E&D, F&A, HR, S&M, IT, Executive Leadership)• Business process owner for product and regulatory master data• Siemens TeamCenter PLM super-user and workflow design contributor• Determination of strategy for and execution of UDI and direct part marking updates for FDA and EU MDR compliance
Gainesville, Florida, United States
Assigned with determination of new requirements (after FDA accessories ruling), process creation, and implementation of a surgeon specialty instrument program to develop FDA Class I and II instrumentation for knee, hip, shoulder, and ankle implants. After completion of the SOPs and successful implementation of the process, I transitioned into a leadership role to manage the special instrument program. In this role, I had the opportunity to build and lead a team of engineers, designers, and machinists dedicated to solving unmet clinical user needs.Other responsibilities included: • Cross-functional collaboration on regulatory and development strategies• Resource allocation of direct team, BU engineers, QA engineers, and RA specialists• Expectation management with sales force and surgeon customers• Technical documentation and specification approvals• Build-out of Smartsheet and MS SharePoint workflows and project management tools• Regular KPI updates to leadership and escalation management• Coordination of procurement, shipping, and accounting processes• Oversight of instrument refurbishment program
Gainesville, Florida Area
• Biologics development - Cartilage repair, bone graft substitutes, cell therapy products • Hip implant development - highly polished cemented stems• Surgical instrumentation development (hip, knee)• Post-market and sustaining engineering• Design control and remediation• Operative technique development
Gainesville, Florida Area
• Pre-clinical cartilage repair models (mouse, goat, pig, horse)• Chondrocyte cell culture and tissue engineering methods• Technology transfer (Taiwan subsidiary)• Alginate-based bone graft carrier formulation• PLGA scaffold fabrication
Athens, Texas, United States
• Cardiovascular fluid management devices• Injection molding processes
• Collaborated with 3 departments on concept development of nanoscale blood oxygenator• Created finite element models to simulate oxygenator channel blood pressure loads to obtain pilot data for federal grant funding
• Designed and built equipment for characterization of thin nanoporous polycarbonate membranes to quantify effects of hydrophobic coatings
• Developed curriculum for Drug Delivery course and held office hours for student support
• Fabricated 3mm to 6mm bioresorbable PLLA stents for peripheral vascular applications
Biomaterials and Tissue Engineering Track
Activities and Societies: AIChe, Tau Beta Pi
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Chris Chapman works for Chapman Collaborative LLC.
Chris Chapman is listed as Medical Device Development Expert | Technical Compliance | Program Manager | MSBME, MBA, PMP at Chapman Collaborative LLC.
AeroLeads has found 1 work email signal at @exac.com for Chris Chapman at Chapman Collaborative LLC.
AeroLeads has found 1 phone signal(s) with area code 352 for Chris Chapman at Chapman Collaborative LLC.
Chris Chapman is based in Gainesville, Florida, United States while working with Chapman Collaborative LLC.
Chris Chapman has worked for Chapman Collaborative Llc, Exactech, Argon Medical Devices, Inc., University Of Texas At Arlington, and Ut Southwestern Medical Center.
You can use AeroLeads to view verified contact signals for Chris Chapman at Chapman Collaborative LLC, including work email, phone, and LinkedIn data when available.
Chris Chapman holds Master Of Business Administration (Mba), Management from University Of Florida - Warrington College Of Business.
Chris Chapman is listed with skills including Biomedical Engineering, Medical Devices, Design Control, Biomaterials, R&D, Quality System, Design Of Experiments, and Tissue Engineering.
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