SHREYAS DIGHE

• Offered strategic counsel and conducted gap analysis on regulatory, quality, and product development strategies across product lifecycle from preclinical stages to market launch
• Delivered expert advice on quality and regulatory matters, assisting clients in meeting procedural and documentation requisites for commercialization and regulatory goals, including regulatory classification, pathway identification, and preparation for Scientific Advice
• Provided strategic direction and project management support for GMP licensing of cutting-edge manufacturing facilities.

• Developed, implemented, and managed Quality Management System (QMS) in compliance with EN ISO 13485:2016 and 21 CFR 820 regulations
• Led successful ISO 13485 Audit as lead auditee, resulting in certification without any non-conformances
• Prepared Technical File for Class I product and secured CE Clearance in accordance with EU MDR 2017
• Orchestrated team efforts to secure Special 510(k) clearance for company product
• Efficiently managed control documents, data, and records related to QMS
• Conducted investigations, CAPA, and root cause analysis for customer complaints
• Primary point of contact for responding to MEDWATCH and other USFDA documents.
• Managed and motivated employees to be productive and engaged in work.

• Orchestrated cross-functional teams encompassing R&D, Operations, Manufacturing, Quality, and Regulatory functions to conceptualize, develop, and launch multiple products for global markets
• Drove innovation and bolstered the company's intellectual property portfolio by co-inventing multiple patents
• Directed the execution of numerous New Product Development (NPD) initiatives in collaboration with interdisciplinary teams
• Spearheaded End-to-End product development lifecycle, encompassing Business case development, Requirements analysis, Design, Prototyping, Verification & Validation (V&V), and Manufacturing transfer
• Led and navigated successful completion of external audits, including CE MDD, ISO 13485, and USFDA audits as the Lead Auditee
• Provided post-launch engineering support, troubleshooting, and resolution for new and existing products to optimize on-field performance
• Played a pivotal role in talent acquisition, retention, and performance management processes
• Conducted comprehensive analysis of processes, applications, and recommended strategic enhancements to drive operational efficiency
• Championed cost reduction initiatives and conducted Value Engineering and Value Analysis to optimize operational efficiency and throughput.

R&D Responsibilities:

• Managed project plans for full product lifecycle.
• Created prototypes, specs, and documentation.
• Translated stakeholder needs into product requirements.
• Designed innovative components and manufacturing methods.
• Conducted thorough testing and analysis.
• Developed CAD models and engineering drawings.
• Improved operational systems and processes.

Quality and Operations Responsibilities:

• Developed and maintained DHF, DMR, and QMS documents.
• Oversaw design verification, validation (IQ/OQ/PQ), and pilot manufacturing for product transfer.
• Provided process-related training and served as SME for Contract Manufacturing activities.
• Ensured robust process design meeting safety, quality, and cost requirements.
• Contributed to successful completion of FDA, ISO, and CE Quality Audits.
• Authored technical documentation for Regulatory Assessments.

• Demonstrated CAD development and prototyping skills for Tongue Drive System (TDS) research project
• It is a tongue operated wheelchair
• Designed and developed PCB casing boxes, enclosures and calibration units
• Assisted in clinical trials of the TDS and data analysis using MATLAB.