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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,…
Business Optimization, Engineering, Analytical Rigor, Technical Expertise, Due Diligence, Critical Business Analysis to Develop/Implement Change for Profitable Growth
We fuse business optimization, engineering expertise, analytical rigor, and technical expertise to help companies perform due diligence, critical business analysis and design/implement continuous improvement programs to achieve profitable growth. Our firm provides expertise in commercial development, new product development, sourcing,…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control
Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge,…
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…
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…
Medical Devices – ENT Devices, Surgical Devices, Cardiac Devices, Renal Devices & Artificial Organ
Expert has over twenty years experience in designing and developing medical device to clinical problems. Also, he has extensive experience as a surgeon having performed ENT head and neck surgeries and assisted in neuro surgeries and other general surgeries. He…
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,…
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…
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,…