Mr. Anim Shrestha is a product development engineer with more than 10 years of combined research, development and validation experience in the medical devices and pharmaceutical industry and in the academic sector in the U.S. Mr. Shrestha has strong knowledge about pharmaceutical/medical device regulations in the U.S. and Europe. In addition, he has extensive experience in product design & development process of medical devices, engineering testing, preparation of specifications, design verification and report preparation.
Mr. Shrestha is Six Sigma Green Belt Certified and has worked for world-renowned and industry leading companies like Covidien and Baxter Healthcare.
Bachelor of Science, Biochemistry, Salem State University, Massachusetts, USA
Master of Science, Biomedical Engineering, South Dakota School of Mines & Technology, South Dakota, USA
Mr. Shrestha’s experiences and technical expertise include the following:
- Experience on Unique Device Identification (UDI) for labeling for Medical products.
- Extensive experience in DOE expertise utilizing Minitab, Gage R&R, Sample Size Determination, Analysis of Variation, Process Capability and Test Method Validation (TMV).
- Knowledge in Patent Application,Product Development Life Cycle,Change Control Management (CMM), CAPAs, Premarket Approval (PMA) and Remediation Process.
- Expertise inNiTi,Ceramics, Zirconia,Composite Materials, Product Characterization,Biomaterial Testing, Mechanical Testing,Hydrogel,Defibrillator, Pacemaker, DES (sirolimus or paclitaxel eluting stents), Polymer based stent (biodegradable)extrusion, injection molding and Spectrophotometers, Chromatography.
- Strong understanding of chemistry/physics of oxidation processes, surface chemistry, texture & potential, materials science principles and application conditions, interface effects.
- Experience with Six Sigma Methodology (DMAIC, FMEA,6S, 5 Whys FMEA, Kaizen).
- Familiar with appropriate FDA QSR and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge.