Akshay Parulkar

Electrode R & d Engineer i (Array R & d Engineer) @Blackrock Neurotech

Salt Lake City, UT, US

Worked on developing implantable devices following required ISO standards & collaborated with multi-disciplinary teams Improved fabrication process of the devices resulting in optimised process repeatability & increased device robustness Designed/ modified CAD models & drawings for Jigs, Fixtures, parts & assemblies & worked on 3d printing & machining Worked on preliminary proof of concept ideas & fabrication/prototyping-related experiments to generate feasibility results Drafted Design documents such as Product Requirements (PR), Design Specifications (DS), Hazard Analysis (HA) & DFMEA Drafted Traceability Matrix, IFUs and deviations for manufacturing documents such as WI, BOM, DT & Drawings Designed packaging for the devices that can go through sterilization & drafted protocol for the packaging validation study Devised V&V protocols for visual, electrical & mechanical characterization & performed tests on the devices accordingly Collaborated on completing Design Control phase, DHF, DMR & provided training to technicians on manufacturing processes Reviewed & modified SOPs teaming up with Quality department. Built devices adhering to GMP & Cleanroom safety procedures Coordinated with suppliers/ vendors for purchasing new raw materials/ equipment and study houses for Biocompatibility studies Qualified equipment and executed system validation activities (IQ/OQ/PQ) per VMP guidelines

Arizona State University

Master of Science - MS, Mechanical Engineering

University of Mumbai

Bachelor of Engineering - BE/BS, Mechanical Engineering