Home Office
California - Irvine
15235 Alton Parkway
Suite 120
Irvine,
CA
92618
- Phone: (949) 336-9001
- Fax: (949) 336-9020
Dr. Nikita Pak is a Senior Consultant at ESi. Dr. Pak has over a decade of experience in mechanical engineering design, primarily focusing on medical device design and testing. This includes evaluating the safety and efficacy of various types of medical devices with cadaveric and surrogate tissue experiments, custom test rigs, and by testing to standards such as ASTM and ISO. He has experience in developing machines and instruments from the design phase through final testing and documentation, including designing devices such as PCR thermocyclers, microfluidic devices, surgical robots, microscopes, cell culture bioreactors, and implantable devices. Dr. Pak was trained as a mechanical engineer with a focus on machine design, manufacturing, mechatronics, and optics and he applies these skills to the world of medical devices.
Dr. Pak is experienced with all aspects of the medical device lifecycle including design, risk management, verification and validation testing, failure analysis and device examination, manufacturing, post-market surveillance, and the regulatory process. He has experience working on all classes of medical devices including surgical tools, bone fixation devices, orthopedic devices, implantable filters, pacemakers, and biopsy markers.
ESi's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.
Contact Us