Responsible for all “back of the house” operations including production, quality, purchasing, sales operations, order fulfillment and sustaining engineering. Managed Somavac Quality Management System. Developed and introduced Business policies for personnel, compliance, travel, etc. - Developed and implemented internal production system, SIOP process and ongoing production. Responsible and executed all Plan -> Source -> Make -> Deliver processes.- Specified, implemented, validated and administrated ERP platform (Oracle’s NetSuite) for customer and supplier management, accounting, production, purchasing and distribution.- Somavac’s Management Representative for the FDA. Managed Somavac FDA Inspection. Oversaw the Quality Management System and worked to continuously improve processes and procedures.- Managed sustaining engineering and cost reduction activities executing plan to reduce portfolio COGS by 52%.- Coordinated and enhanced engineering activities with external contractors for supplemental services.- Planned and executed buildout of and transition to a new facility with no reduction in OTD.- Managed direct and indirect purchasing, implemented strategic purchase order systems, contracts and controls.- Established and managed product distribution processes (e.g. sales rep inventory, production evaluations, delivered orders, commercial sales, etc.)- Identified and managed the ASL; negotiated pricing, executed purchases, managed audits and SCARs.- Established internal management board; acted as controller managing AP, AR, budget by department and establishing company’s chart of accounts- Supported and participated in fundraising efforts, pitch deck development, and financial modeling.

Responsible for:- Product development: concept, design, engineering, validation, sustaining.- Coordinating and enhancing production and engineering activities of all external contractors (supply chain, quality control, software development, etc.).- Managing direct and indirect purchasing.- Overseeing the Quality Management System while improve process and procedures.- Supporting IP and regulatory submissions.

Adjunct: Graduate Level Technical Project Management (ENGM 612)

Developed comprehensive, global product and procedure strategies, including regional healthcare economics, market trends, business cases, and product roadmaps. Supported development and execution of corporate five-year strategic plan (16% CAGR revenue) for Global Ear, Nose and Throat (ENT) Business Unit.- Established awareness around healthcare economics as part of triple aim (US). Integrating economic factors into development strategies.- Defined mid and long-term strategic direction driving global product roadmaps and technology development plans.- Managed and directed business activities as active member of Global ENT Business Unit Management and Global ENT Executive Committee. Travelled internationally 12-15 times per year.- Outlined disruptive strategies defining research plans and future (10 yr. plus) approaches to medical procedures.- Managed multiple relationships with surgeons (US, EU, AUS, etc.) to verify target strategies, understand market conditions, evaluate product development opportunities and potential procedure risks.- Developed process for sales organization assessments to ensure “blind spots” are understood and addressed. Executed workshops with emerging sales organizations to define investment strategies, sales plan, and ROI.- Worked with R&D centers in Germany, Japan, and US to develop products and technologies meeting the needs of the customers (surgeons, C-suite execs, purchasers, nurses, etc.)- Identified potential collaboration partnerships and acquisition targets; assessed strategic and clinical relevance. Developed proposals for Global ENT Business Unit and Olympus Corporate Executive Committee.- Proposed and executed pilot programs with multiple companies for collaboration activities with various Olympus sales organizations.

Site leader with direct (R&D and Operations) and indirect (Marketing, Quality, HR, etc.) reports. Transitioned site from a dated manufacturing facility to a state-of-the-art production and R&D facility designated as Olympus’ Global ENT Competence Center. Produced high mix – low volume portfolio. Worked as member of Olympus Surgical Technologies America’s Executive Committee.- Developed, documented and introduced multi-year site improvement and expansion plan enabling growth and absorbing additional production.- Established a culture of transparency and mutual responsibility across direct and indirect departments.- Changed site culture from one of “make do” to “exceed the customers’ expectations” at all levels of the organization.- Improved site level quality awareness through dedicated “Pillars of Quality” initiative retraining ALL employees re- establishing importance and awareness of both quality and Quality Management System.- Introduced Production Risk Management system identifying process and equipment risks resulting in primary and secondary backup plans.- Co-chaired Global ENT Strategy Committee representing multiple Olympus organizations, defining a long-term direction enabling significant growth in the ENT space.- Established local operations boards controlling non-product development projects (Value Engineering, Sustaining, 5E, CAPA) ensuring timely execution of projects AND defining and establishing Business Center role in production sites allowing for localized responsibility and execution (including purchasing, ME, R&D, warehousing, etc.).- Implemented technical growth strategy increasing technical competencies across site. Established new competencies in biomaterials. Established site as North American center for Production Technologies group.- Eliminated multi-year chronic backorders on seasonal, commodity portfolios, developed and initiated plans for multi-source, minimal risk production.

Manage a development budget for new products and technologies for otolaryngologists. Expanded department competencies to establish the site as Olympus’ technical domain for powered instrumentation, manual hand instruments, and otology implants. Implemented best practice process for design control, risk management, & project management. Released multiple Class I, II and II a/b devices.• Developed project justifications and presented to project review boards (executive and peer level).• Established and directed product development activities to ensure consistency with the ENT portfolio growth plan.• Worked directly with doctors in surgical and research institution settings to define specific design criteria.• Introduced a “fail early, fail often” concept establishing early and parallel testing plans to minimize product and project risks while concurrently developing competencies within the department.• Strengthened relationships between Operations, R&D and Upstream Marketing integrating the groups into the development process from inception through commercialization.• Developed portfolio management, formalized resource management and project-based financial tracking.

Directed corporate New Product Development (NPD) process. Established new department to ensure sustaining and NPD developments were consistent with corporate portfolios and product roadmaps. Interacted with global R&D centers on compliance, complications, and improvements to process.- Led multidiscipline executive level team moving from multiple new product development processes to one harmonized process. Conducted internal stakeholder meetings to assess needs / analyze failures for new NPD process.- Developed harmonized stages, gates, and documentation for all new product development efforts. Implemented improved design control and risk management processes compliant with IEC and ISO requirements.- Established program manager positions in Boston and Minneapolis (previously established in Memphis); hired / supervised employees managing overall programs and portfolios in ENT, Surgical Energy and Endoscopy divisions, supporting R&D in USA, UK and Israel.- Ensured regulatory compliance through regular communication with Global VP of RA / QA (FDA and ISO).- Established project reporting to executive management, relaying all aspects of projects including timeline slips, budget variations, resource positions, and interdepartmental participation.- Managed weekly R&D center review meetings assessing project status, red flags, technology sharing opportunities, and departmental issues.

R&D leader for all ENT devices developed in Bartlett, TN facility.

Program Manager for powered surgical ENT devices.