Denver Faulk
Director of Biocompatibility - Philips Sleep and Respiratory Care
- Role
- Director of Biocompatibility - Sleep and Respiratory Care at Philips
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Denver Faulk
Denver Faulk, PhD is a seasoned expert in medical product development, specializing in biocompatibility, clinical engineering, biomaterials, regenerative medicine, and artificial organ technologies. With 20 years of experience, Dr. Faulk has successfully led projects in medical device design and development, emphasizing risk management, systems engineering, and adherence to ISO and FDA standards. His expertise also extends to biocompatibility testing and usability engineering.Dr. Faulk\'s laboratory and research capabilities are comprehensive, encompassing pre-clinical animal models, ISO 10993 and ISO 18562 biocompatibility testing, packaging development, cell culture, sterilization protocol development, biologic scaffold production, immunolabeling, histomorphometry, and advanced imaging techniques such as fluorescent and scanning electron microscopy. He is also skilled in uniaxial and biomechanical testing.Proficient in software tools like SPSS, ImageJ, Cell Profiler, Matlab, SolidWorks, and AutoCAD, Dr. Faulk is well-equipped to handle complex data analysis and design challenges. His scholarly contributions include 16 peer-reviewed journal publications, 30 national and international presentations, two book chapters, and five filed patents.Dr. Faulk has demonstrated strong leadership in project management across academia, industry, clinical engineering, and health-tech startups, making him a valuable asset in both research and development settings.
Experience
Director of Biocompatibility - Sleep and Respiratory Care
Dec 2021 — Present · Pittsburgh, PA, US
Direct and lead a team of biological safety engineers, toxicologists, and material scientists conducting biocompatibility evaluation of all products across the S & RC product portfolio.• Develop and implement biocompatibility resourcing strategy to provide support of all business category needs.• Interact directly with functional groups including R&D groups, Business leaders, Hardware Engineering, Regulatory, Analytical Chemistry, Quality groups and external CROs.• Oversee development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical File and 510k Submissions.• Remediate Philips processes for product compliance to ISO 10993 and ISO 18562 to meet state of the art expectations from all global regulatory bodies. • Work with cross functional key stakeholders to ensure that new biocompatibility requests are resourced and supported in alignment with business priorities. • Establish new procedures that further improve biological testing of materials and products.• Partner with development teams to ensure that quality materials are selected for use to drive successful product testing.• Oversee consent decree remediation activities for Biocompatibility and respond to Competent Authority Questions involving Biocompatibility.
Education
University of Pittsburgh
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
2011 — 2015
Carnegie Mellon University
Bachelor of Science (BS), Chemical and Biomedical Engineering (Double Major)
2004 — 2008
Imperial College London
Chemical Engineering
2006 — 2007
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