Siddegowda VR

Innovative and results-driven Principal Scientist/Chemical Engineer with 15+ years of expertise in R&D leadership, process development, and regulatory compliance across medical devices, membrane technologies, and water treatment systems. Proven track record in chemical formulation optimization, material science, and product lifecycle management, with contributions that enhanced patient safety, reduced therapy costs, and enabled FDA IDE submissions. Skilled in cross-functional team leadership, lab accreditation, and global regulatory standards (NSF, ISO 13485, ISO 17025, 21 CFR 820), with a reputation for driving innovation, solving complex technical challenges, and delivering compliant, cost-effective solutions for healthcare and industrial applications. R&D Leadership: Medical devices, sorbent cartridge development, and membrane-based water treatment technologies, formulations, and water purification solutions. Regulatory Compliance & Quality: Expertise in NSF (60/61/53/58), UL 94, FDA IDE submissions, ISO 13485, 21 CFR Part 820, and packaging compliance (ISTA 2A). Analytical Method Development & Lab Management: ISO/IEC 17025, CAPA, DHF, FMEA, and laboratory accreditation & audits. Material Science & Biocompatibility: Polymer optimization, chemical compatibility testing, and biocompatibility assurance. Product Verification & Validation (V&V): EVT/DVT, design verification/validation, packaging, and compliance verification. Instrumentation Expertise: GCMS, FTIR, ICP-MS, ICP-OES, TOC Analyzer, UV-Vis, AAS. Team & Project Leadership: Global collaboration, supplier management, procurement, and Agile tools (Agile, Jira, Jama, Smartsheet). Enhanced patient safety through chemical formulation innovation — identified hazardous toxin leaching from sorbent cartridges, redesigned formulation by optimizing acid concentration, and achieved 90% toxin reduction, earning the Compass Global Award. Optimized material selection for FDA IDE submission — replaced Ultem with Polysulfone after identifying erosion issues under high temperatures, enabling successful Investigational Device Exemption (IDE) submission to the FDA. Redesigned sorbent cartridge architecture — solved channeling issues in chemical filtration by introducing a honeycomb model design, ensuring uniform resin packing, effective toxin removal, and improved disinfection performance. Achieved ISTA 2A packaging compliance — resolved repeated failures by innovating packaging with integrated foam, ensuring regulatory compliance and safeguarding chemical formulation stability during distribution.