Executive leader for therapeutic respiratory device company producing 10M+ devices annually, generating multi-million dollar sales across North / South America and Europe, with 100 employees across US and Mexico. Oversaw total team of 100 employees with seven direct reports, including director of strategic accounts, director of business development, director of engineering and quality, director of supply chain, director of HR, plant manager, and finance manager. Led P&L management, ensuring financial performance through cost control and revenue forecasting, driving operational efficiency to improve EBITDA and cash flow. Created objectives and goals and right operating cadence to drive team accountability for results. Led strategic planning process to identify growth opportunities over three- to five-year horizon. Reviewed and approved major cash decisions in collaboration with finance and supply chain leaders. Conducted regular reviews of production plans and performance to address risks and align with strategic goals.Key Accomplishments✦ Business Turnaround ✦ Restructured the business to recover from a major revenue decline and resulting drop in EBITDA caused by a COVID-related market shift in the customer base.✦ EBITDA Growth ✦ Improved EBITDA 810 basis points within 12 months through freight and material expense reduction and strategic pricing initiatives.✦ Cash Flow Improvement ✦ Increased operating cash flow by 2x through strategic inventory management, accounts receivable optimization, and operational footprint simplification.✦ Business Growth ✦ Expanded opportunity pipeline in strategic growth areas by 3x within 12 months.✦ Operations Transformation ✦ Reduced backorders to nearly zero and achieved 95% on-time delivery, elevating on-time-to-request performance from 64% to 92%.✦ Workforce Engagement ✦ Enhanced workforce engagement, increasing the eNPS from -30 to 20 and achieving zero safety incidents over the last 17 months.

Led start-up medical device company focused on non-invasive sample collection devices for genetic, health, and infectious disease diagnostics, with sales across US and Europe. Managed team of 8 senior leaders, including R&D scientists, director of engineering and quality, director of sales, director of marketing, director of supply chain, finance manager, and HR director.Identified target markets and developed product strategy for launch of saliva collection devices, including customer engagement to validate value propositions and uncover market pain points. Oversaw product roadmap and regulatory strategy, ensuring product functionality aligns with customer needs, cost targets, and FDA classifications and registrations.Built strategic partnerships and collaborated with key customers, including top national laboratories and consumer diagnostics companies, to drive commercialization and growth. Managed annual operating budget and conducted regular product development progress reviews, regulatory strategy meetings, and weekly staff meetings to align team efforts.Key Accomplishments✦ Business Unit Creation ✦ Established an independent operating entity from the ground up, including site identification, lease negotiation, shared service agreements, and securing essential operational insurance; recruited a skilled workforce and achieved ISO13485 certification within the first year.✦ Commercial Strategy ✦ Developed and implemented a commercial strategy based on primary and secondary research, leading to the successful launch of the first FDA-registered class I medical device within 12 months.✦ Strategic Partnerships ✦ Successfully developed strategic partnerships with major consumer genetic companies and national laboratories.✦ Regulatory Expertise ✦ Executed a dynamic regulatory strategy for a 510k submission, identifying a suitable predicate device, devising a testing plan, and completing the submission ahead of industry standards.

• Led global product development and R&D teams, managing 72 employees across 8 manufacturing facilities in the US (3), Europe (3), and Asia (2), as the company expanded 4x in revenue and doubled its workforce from 500 to over 1,000 employees.• Directed a team of 9 senior leaders, including directors across various development functions, and indirectly managed 63 engineers, scientists, project managers, and technicians.• Spearheaded the creation and execution of company strategy, leveraging technology and innovation to position the company as a product innovator in the market.• Implemented best practices across global development teams.• Managed the transition of new products from development to production, ensuring seamless integration and collaboration between technical and operational teams.• Conducted technical due diligence for new acquisitions in collaboration with the Filtration Group deal team.• Negotiated contracts for vendor agreements, supply agreements, and development agreements.Key Accomplishments• Organizational Expansion & Revenue Growth: Developed and implemented a global engineering team structure that supported growth of 4x in revenue.• New Product Launches: Consistently exceeded new product revenue targets, increasing annual revenue from 2.5x and growing the number of launched projects from 2x.• New Revenue Streams: Expanded engineering service fees 5x in 4 years by standardizing global sample, testing, and tooling charges.• Strategic Commercial Initiatives: Led strategic commercial initiatives, resulting in successful multi-million dollar product launches with Global Fortune 100 customers.• Award-winning Innovation: Recognized for innovation success, earning the Outstanding Corporate Innovator award from PDMA, joining prestigious companies like 3M, Pepsi, and Starbucks.• Acquisition Integration: Integrated a development team from an acquisition of an equal sized organization, expanding global development locations from 4 to 8.

• Award-winning R&D: Led R&D team to introduce an innovative elastomeric material for the cosmetic industry earning the InnoBeauty Rising Star New Product award.• Portfolio Collaboration: Established a technical leader forum across FG portfolio companies, resulting in significant capital savings through shared testing and manufacturing, and generating an enhanced innovation pipeline.• Process Improvements: Implemented filtration simulation software, reducing development time and resources needed for physical samples, and deployed agile product development methods to enhance project velocity and streamline priority tracking, cutting critical development activity times.

• M&A Success: Implemented data-driven metrics for funnel management, leading to an extremely successful valuation and sale to Filtration Group from Aurora Capital.• Organizational Restructure: Restructured the development organization, merging regional teams to improve sales support and streamline operational processes.• Exceeding Goals & Budgets: Consistently delivered projects ahead of schedule, surpassing new product revenue goals by 15% annually while maintaining expenses below budget each year.• Process Improvements: Increased project efficiency by 25% through the installation of a new product lab, accelerating sample creation and production transfer; deployed a product lifecycle management system that enhanced data sharing and collaboration, resulting in a 25% improvement in global teamwork.

• Expanded territory by 27% while boosting profitability.• Executed strategic pricing actions.• Territory earned annual sales award in 2012 for new development projects that expanded territory size by more than 25%.

As Governance Chair and a Member of the Executive Committee, I support the overall organization strategy and execution providing input and oversight of Board and organization roles & operating framework.Georgia Bio represents more than 250 pharmaceutical, biotech and medical device companies, universities, research institutes, government groups and other business organizations involved in the development of products that improve the health and quality of life people worldwide.

• Managed both product development programs as well as a portion of the engineering team working in product development.

• Managed all engineers at production facility. • Oversaw all equipment and processes at the production facility.

• Responsible for developing project plans to launch Class I, II, and III Medical devices.• Coordinated and participated in the design, development, and manufacturing of the devices including selecting, qualifying, and launching plastic injection molds/vendors, as well as in house and overseas manufacturing.

• Responsible for the design and development of Class I, II, and III medical devices including design for manufacturing, design of injection molded plastic parts, specialty sharps (needles), DFMEA, PFMEA, ISO13485 compliance, ISO Bio-compatibility compliance, selection and setup of injection molding vendors and tooling, product turnover to manufacturing and process verification and validation (IQ, OQ, PQ).

• Worked with engineering group to support efforts to design and develop Class I, II, and III medical devices including design for manufacturing, design of injection molded plastic parts, specialty sharps (needles), DFMEA, PFMEA, ISO13485 compliance, ISO Bio-compatibility compliance, selection and setup of injection molding vendors and tooling, product turnover to manufacturing and process verification and validation (IQ, OQ, PQ).