Amprion, Inc. is developing and commercializing novel technologies for diagnosing neurological disorders.Spearheaded strategic initiatives in project management, system engineering, data analytics, technical documentation, and QMS development. Achieved accelerated career advancement through exceptional performance and leadership.• Championed commercialization strategy by directing SYNTap® qualitative α-synuclein assay development from clinical laboratory transfer to market readiness.• Architected and implemented comprehensive FDA-compliant design controls, risk management and software validation frameworks, establishing robust product development process.• Orchestrated Critical Design Reviews across development phases, securing 100% stakeholder consensus for strategic project advancement.• Engineered sophisticated patient classification algorithms, achieving industry-leading >90% assay accuracy rates.• Designed and deployed assay data analysis software, delivering >10-fold efficiency gains and dramatically enhancing project agility.• Directed development of 100% Verification/Validation documentation, ensuring complete regulatory compliance.• Co-authored groundbreaking 2023 Journal of Neurology publication educating thousands of neurologists on Parkinson's disease diagnostic accuracy innovations.• Expanded market potential ~20-fold through pivotal contributions to 2024 Neurology publication on dementia diagnostics using alpha-synuclein-SAA methodology.• Executed cybersecurity oversight for clinical laboratory operations, maintaining zero audit findings in critical compliance areas. • Orchestrated mission-critical data transfers in support of leading pharmaceutical corporations and leading academic research institutions projects.

• Product Development Project Manager • Lead implementation of Design Controls and Risk Management for Product Development• Validation protocols and reports• Scientific publications• Experimental design• Data analysis including software development• Patient classification methods development• Experimental uncertainty characterizations using Monte Carlo simulation techniques• Quality Management System Development • Authored design control, risk management, and software VV SOPs• Editorial support

Qualigen, Inc. manufactures medical equipment for measuring thyroid-stimulating hormone, free T4, human chorionic gonadotropin, PSA, free PSA, vitamin D, SHBG, and testosterone in blood.Led diverse cross-functional teams spanning executive management, engineering, R&D, clinical research, customer support, quality assurance, and operations. Demonstrated technical excellence in next-generation development and business optimization, resulting in accelerated career advancement.Next Generation Development:• Directed comprehensive CLIA Waived device development lifecycle from Viability through Verification phases, orchestrating internal teams and external resources.• Developed comprehensive Design Input requirements incorporating human factors engineering principles, establishing detailed software specifications for advanced assay mathematics and statistical analysis.• Authored and secured approval for Risk Assessment and FDA pre-submission documentation supporting CLIA Waiver application.• Orchestrated seamless coordination between external design house and internal technical teams, driving software/hardware development, system optimization, and verification processes.• Invented and secured primary patent (US9903799B2) for innovative quantitative, lateral flow-based blood separation technology.• Pioneered a real-time image analysis system for positive sample verification, resulting in patent US20180342062A1.• Key contributor for reagent pack design, culminating in patent USD830573S1.• Engineered sophisticated VBA software solution enabling seamless integration between instrument systems and reagent lot-specific signal concentration curves.

Beckman Coulter Inc. is a Danaher Corporation company that develops, manufactures, and markets products that simplify, automate and innovate complex biomedical testing.Drove product development and production support excellence, achieving three promotions through demonstrated technical leadership and innovation.• Key contributor to integration and verification for multiple flagship platforms, including CX3, CX4/5, CX7, DxC, LX20, and LabLyte systems.• Established organizational authority on calibrator/control value assignment and advanced data analytics.• Directed successful development and commercialization of strategically important Immage Cystatin C immunoassay.• Spearheaded high-sensitivity CRP standardization initiative, delivering full-scale implementation.• Pioneered spectroscopic parameter optimization process for Valproic acid assay, achieving ~30% improvement in assay precision.• Engineered innovative control value assignment process, generating >$10,000 annual cost reduction and securing U.S. Patent US7312083B2.• Developed specialized value assignment methodology for Synchron Prealbumin assay, published in Clinical Chemistry (May 2007), ensuring IVDD compliance and traceability.• Invented a novel robust variance estimation method, securing U.S. Patent Application 20060241904 with accepted claims.• Published groundbreaking research in Clinical Chemistry (November 2002) examining analytical error impacts on cardiac risk assessment.• Architected comprehensive IVDD compliance process, developing advanced SPLUS programs and Monte Carlo simulation tools for calibrator uncertainty characterization.