Founded Occam Design – division of CreoSalus specializing in design and manufacturing of innovative medical devices and peptide synthesizers. Established and grew high-performance development team. Delivered numerous medical devices to the market including; Inscope, Cobra Introducer, Ouchless Needle and Alkymos. Leading development and manufacturing of most innovative peptide synthesizer from concept to market.• Lead R&D and Manufacturing departments including engineering, quality control, regulatory, facility maintenance, customer success and sales; manage $3.5M P&L; key contributions to strategic roadmap and fiscal management• Established Occam Design as division of CreoSalus to identify and build relationships with clients, assess product viability, and develop pipeline; manage full lifecycle from concept to testing and market release; generated $2M revenue growth in 2020, achieved profitability; on track for 75% revenue growth in 2021• Initiated and led construction of 17,000 sq. ft. GMP facility, defined new functions and recruiting needs, expanded development and manufacturing capabilities, tripled development projects and doubled manufacturing capacity • Analyze viability of client device and business proposals, identify market trends to recommend optimal design; facilitated positioning of an interventional medical device client with a me-too proposal to become a market leader supplying a revised, cutting-edge device to yield higher profitability• Provide customized mentorship to medical device entrepreneurs and established companies for business and product development cycle management, manufacturing operations, and industry regulations• Aided in growth of CreoSalus pharmaceutical division and acted as a liaison between pharmaceutical division and engineering team.

• Devised and executed growth agenda to enable expansion from peptide synthesizers market to diversified medical devices; designed and manufactured innovative devices for startups and niche market companies• Established team of five engineers, software developers, and customer success managers to design and develop peptide synthesizers for pharmaceutical companies and research universities; consulted for startup medical device companies on development cycles and marketing strategy; second employee hired• Aligned teams and processes for manufacturing, quality, and compliance with client needs; supported multiple projects ranging from regulatory control to Class II devices; led NIH animal study projects across two universities by organizing vendors and suppliers to ensure compatibility• Formulated use cases and identified partners for design and development of bespoke Porous Brain Infusion Catheter; established collaboration with Duke University and University of Kentucky, partnered with neurological drug manufacturer; secured $3M SBIR phase II grant • Recruited and built team, customized interviewing methodologies, trained other managers, developed onboarding and training programs, and implemented systems and tools to achieve industry-leading mechanical system, embedded firmware, electronic hardware, and software capabilities• Developed and deployed continuous production capabilities; defined quality testing and validation procedures, introduced repair service offering; implemented FDA 21 CFR Part 11 and ISO 13485 medical device standard, achieved regulatory compliance; doubled production capacity and reduced client downtime by 20%• Utilized risk-based design methodology for development of in-home electronic medical device; led development from concept to verification, validation, and manufacturing; conducted 60601 testing and authored 510K submissions; received clearance for product marketing

• Led series A fundraising, research and development, and clinical trials of continuous cervical monitoring device; formed joint venture with device inventor, drove product development, and led manufacturing• Negotiated funding and operational deals to facilitate sustainable development despite limited funds; identified and pitched to angel investors; won Vogt Award for early stage community-benefiting products• Identified and built relationships with universities for animal testing and with OB/GYN doctors for product evaluation; submitted three patent applications and generated buy-in from target medical community

GrindMaster is a global leader in the beverage dispensing equipment industry. The company currently markets a comprehensive line of quality beverage dispensing equipment for hot, cold and frozen beverages.Improved existing design of cold powdered beverage dispenser Developed digitally controlled brewers for restaurants and coffee shopsCreated new manufacturing line for assembly of digitally controlled brewers Supported manufacturing plants in different parts of country and worldStarted new manufacturing line for assembly of airpot racks in Thailand

• Led product design and development team to develop mid-urethral sling system to treat urinary incontinence; served as manager for daily operations and project budgets • Created new business opportunities and enhanced existing product line by increasing manufacturing capability, reducing operational costs, and introducing three supplementary devices

• Constructed prototype for human clinical study of incontinence therapy catheter and modeled components for new peristaltic infusion pump, utilizing SLA, FDM, and SLS rapid prototyping equipment; achieved regulatory compliance in accordance with ISO 9001• Designed perfusion system for stroke therapy application, led component procurement and vendor selection process; conducted process validations, installation qualifications, and operational qualifications for manufacturing equipment; introduced motion control to enhance manufacturing automation

Developed motion control hardware and software programming for the automation of manufacturing processesPlayed vital role on project teams designing and developing electromechanical medical equipmentModeled and built components using SLA, FDM and SLS rapid prototyping equipmentDesigned components and assemblies for a new peristaltic infusion pumpCoordinated component procurement and vendor selection