Mr. Anim Shrestha is a product development engineer with more than 7 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.