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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…
Mobile Cellular Telecommunications Handset, BTS, TRX and EnodeB Development (GSM 2G, GPRS, EDGE, UMTS 3G, LTE 4G, LTE-A); 3GPP ETSI Protocols [NAS/AS]; Software, Systems and Standards; IPv6, M2M (IoT)
Expert is a professionally registered chartered engineer and a senior member of the IEEE, with extensive software and systems development experience (solutions provider). His strengths are his innovation, pragmatic approach, reliable delivery and ability to integrate quickly into a project…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Soil Properties,Stormwater and Flooding, Waste Management, Landfilling, Groundwater, Coal Ash, fly Ash landfills, Hazardous Waste
Expert has a Ph.D. and over 90 publications in specialized areas. He has carried out expert consulting, research, and provided expert advisory services. He was hired by a legal firm to provide expert assessment of flooding that resulted due to…
Program Management, Quality Systems, Strategic Improvement Initiatives, Quality Assurance
During the 20 years professional life, Expert held a variety of global positions of increasing responsibility in all aspects of program and quality management including Portfolio management, New Product Introduction program management, Strategic Planning, Development on new product introduction methodology,…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
ISO 9001, ISO 13485 Aerospace, Medical Devices, Machined and Fabricated Parts, Validations
Expert has written world class mangament systems from scratch including all 4 tiers of documentation. Expert has a track record of supporting flawless registration audits and successfuly implementing systems for small shops and companies that often struggle with such endeavors.…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Statistics and Bioinformatics, Software Design, High Throughput Genomic Technologies
Experienced scientific and business leader with a background in business, personal and project development and management, focused on data analysis consulting and user centric analytical software design and development. Over 19 years of research and statistical analysis experience. In addition…
International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…