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Expert ID: 731971 California, USA

Expert in Optics optoelectronics optical systems fluorescence sensors medical biotech instrumentation

Expert's core specialty areas include electronics (sensors, embedded systems, optical data transport, eCAD, programmable logic/VHDL, ARM, AVR, FPGA, DSP), software (Linux/Windows, C/C++, Java, assembly, Python), and optics (systems level design to ray trace/non-sequential modeling using Zemax, Matlab). Expert has served…

Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 735076 Massachusetts, USA

Expert in Medical Devices, Diagnostics, Digital Health

Expert has 20 years of leadership experience in medical device/life sciences marketing in small start-ups and Fortune 100 companies. Following an industry career Vice President of Marketing for Oridion (acquired by Covidien) Medical, Director of Marketing for Philips Medical, and…

Expert ID: 735921 Georgia, USA

Expert in Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt

Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…

Expert ID: 735010 Texas, USA

Expert in Lean Business Process Improvement and Business Strategies

Expert is an accomplished business process and management consultant with a track record and recognition as an ace in his field. A change agent with expertise and experience in LEAN business transformation and change management, Expert has 20 years' experience…

Expert ID: 733368 Massachusetts, USA

Expert in Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain

Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…

Expert ID: 731924 Illinois, USA

Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant

BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…

Expert ID: 731095 California, USA

Expert in Medical Product Design and Development

I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers…

Expert ID: 730569 Canada

Expert in Product Design and Manufacturing (Medical Devices, Electronics, Opto-Mechanical)

For the last 20 years, Expert was designing product and piecing up various parts using different materials and processes. Her expertise lies in designing plastics parts, sheet metal, and metal casting. In Expert's career, she worked with suppliers to deliver…

Expert ID: 730258 California, USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…

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