• Executed the development of local, regional, and global regulatory strategies.• Authored and maintained elements of Risk Management Files (RMF) and Design History File (DHF) for class II medical devices.• Anticipated regulatory obstacles and emerging issues throughout the product lifecycle and developed solutions.• Determined requirements and options for regulatory submission, approval pathways, and compliance activities.• Established and implemented equipment qualification activities utilizing MSA and SPC for FDA 510K application.• Facilitated US FDA regulatory information and guidance for product development and planning throughout the product lifecycle within the organization• Prepared and submitted electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines• Communicated with US FDA regulatory authorities before and during the development and review of a regulatory submission.• Collaborated with cross-functional teams for interactions with regulatory authorities.

• Established the manufacturing process to ensure product quality, reduce cost by utilizing lean manufacturing tools like kaizens, mistake proofing, statistical process control, standard work to ensure process stability, and drive continuous improvement decisions.• Initiated, researched, and implemented additive manufacturing/3D printing from design through production.• Supported customer, regulatory and internal audits. • Organized customer meetings, analyzed customer inputs and presented manufacturing solutions.• Trained in FDA QSR 21 CFR 820 and ISO 13485.

- Developed a model to utilize inventory more efficiently to generate a potential annual freight cost savings of $48,000.- Formulated a model in excel macros to validate EOQ and reorder point levels to reduce cost tied up in inventory. - Designed multiple layout proposals on SmartDraw for firm’s new warehouse. - Learned advanced excel operations like macros, conditional looping, pivot tables and V-lookup’s.

•Implemented SPC techniques to ensure process stability and drive continuous improvement decisions.•Supported process improvement and variability reduction efforts using Lean Six Sigma tools and methodologies. •Determined quality improvement parameters by applying statistical methods like Ishikawa’s Cause & Effect-Fishbone diagram, Pareto chart, Histogram).•Collaborated with customers and suppliers to support audits.•Supported cross-functional team in updating APQP manuals.

•Explored the methodology of fabricating a penstock on site. •Modeled a penstock in Solidworks, designed to run two turbines of 48MW each. •Reported data from my observations at fabrication site.•Prepared a cost report which earned laurels from the company.•Learned advanced excel operations like pivot tables and charts, data visualization, solver etc.