Employee #2 at a Biotech / Med Device Company.Implement Quality Management System.Design and Implement Product Development Process.Customer interviews and customer requirements specifications.Supplier / Vendor Management.

For over 20 years, I have been helping Fortune 500 businesses refine strategy, launch products, implement LEAN 6 Sigma manufacturing systems, optimize inventory and improve employee engagement. Now I bring Fractional and Affordable services to small and medium businesses. Start Ups - Let me help you build a business around your product.Established Businesses - Would you like to increase your profitability, implement systems and processes to reduce variability and chaos, or would you like a fellow leader who can help you manage and maximize your organization.Exiting - Your business valuation will be based on some multiple of profit. You will also increase your valuation multiple if you have a strong team and solid processes and systems. Let’s discuss your current state.Strategic Simplification is my process for identifying the largest impact possible with the minimal level of effort, i.e. the biggest bang for your buck.

● Responsible for Manufacturing multiple medical devices in multiple locations.● Led the manufacturing organization to successful FDA PMA audit with zero findings.● Partnered with R&D to resolve product / machine challenges.● Ramped production for successful launch of two new products for the Detour therapy.● Increased productivity by over 20% on the primary product in each facility.● Created metrics for measuring productivity in individual value streams which allowed us to identify, understand and improve productivity and predictability.● Reduced WIP inventory by 33% (500K) in 6 months.● Mentored Ops, Engr and R&D teams to create a new LEAN line layouts to reduce waste and increase productivity. ● Instituted MFG / ENG Daily GEMBA walks for both facilities to improve problem solving.● Created Supply Planning and Scheduling tools for the new Detour product.● Collaborated with suppliers to improve On-Time-In-Full metrics and improve lead-times.● Mentored managers in the Manufacturing, Engineering, Quality and Supply Chain Departments.● Partnered with R&D to develop solutions to complex component situations.● Addressed performance issues in my department, which led to increased employee satisfaction and productivity.● P&L responsibilities for two manufacturing sites.

● Responsible for Supply Chain, Sourcing, Manufacturing, Quality, Regulatory, Continuous Improvement, Shipping/Receiving and Repairs in a highly regulated environment.● Led supplier sourcing, development and contract negotiations for critical suppliers and PCBAs both domestic and overseas.● Implemented APICS-based ROP, ROQ and MOQ into ERP system. ● Created supplier audit form (and metrics) and led supplier audits.● Performed supplier risk analysis on current and potential suppliers / OEMs.● Responsible for negotiating Supplier Master Agreements.● Developed make vs buy process and led analysis / evaluations.● Reduced inventory by 25% by implementing APICS best practices and implementing consignment agreement with Asian ODM manufacturer.● Developed Preferred Availability program to drive sales toward higher volume products and ensure that we had adequate supply of preferred items. Went from 80% of volume from 20% of products to 90% of volume from 10% of products.● Increased On-Time-To-Request from 92% to 96% while decreasing inventory by 25%.● Grew production capacity 30% in two years without increasing manufacturing headcount, through the use of LEAN initiatives.● Implemented manufacturing controls reducing inventory inaccuracies.● Led warehouse layout activities for new warehouse, ● Led ERP-based bay / shelf location project to improve inventory accuracy / efficiency.● Created job descriptions / path for promotion.● Decreased COGS by >6% vs same quarter previous year (27.4% vs 29.3%) ● Strategy Planning, guided by Rotham School of Business (led by mentees of Lafley and Martin of Playing To Win.)● Created and Implemented cross-functional Project Management practices and schedules that led to improved project/product release timing and collaboration between cross-functional groups.● Created and Implemented DMAIC problem-solving program for all employees, with 30 DMAICs completed in the first year.● Updated Quality Manual and Quality Policies.

● Santa Ana Site Lead for Structural Heart and member of the Structural Heart Value Stream Operations Leadership Team. Direct responsibility for 240 employees.● P&L responsibility for $30M operation, across 7 clean rooms, 240 employees.● Maintained Best-In-Class employee engagement with scores above 80.● Participated in Corporate Strategic Planning and collaborated with manufacturing in USA, Mexico and China.● $500K positive to AOP plan in first two quarters through operational and yield improvements.o Led and coached cross-functional tiger teams and LEAN transformations to quickly solve yield, capacity and supply constraint issues while maintaining compliance to applicable quality regulations. o Mentored LEAN leaders and complex cross-functional teams as they led line transformations and continuous improvement projects with the use of DMAIC processes, Kaizen events, DOEs, A3s, problem solving activities and Gemba walks.

• Responsible for management of 4 production lines (200+ employees) for Surgical and Transcatheter Heart Valves. • New Product Introduction for two new products.• Strong people leader who enjoys my team and wants to provide a great work environment.• Increased Engagement score by 13 points to 85% in one year.• Mentored LEAN leaders as they led line transformations and continuous improvement projects with the use of DMAIC processes, Kaizen events, DOEs, A3s, problem solving activities and Gemba walks.• Introduced LEAN principles and productivity tools; such as, 1 piece flow, Pull vs Push, line balancing, First Time Quality, productivity metrics and visual management.• Utilized respect and positive reinforcement to help Supervisors develop into leaders and increase the engagement of their teams.• Introduced an environment of accountability using SMART goals to help the team focus and become successful.• Ramped production 500% in 4 months due to unanticipated market growth in demand.• Increased productivity by >60% on the Evolut R line and >20% on porcine surgical valves.• Training compliance increased from ~80% to ~100%.• Champion of projects to increase yield and implement new systems. • Proactively led audit readiness activities to reduce audit findings and teamed with Quality and Engineering to ensure that corrective actions provided more robust systems and processes. • Developed forecasting model that decreased labor $ variance to <5% vs prior > 10%.• Significantly reduced cost variance in yield, labor spend and other burden / cost center expenses.

• Collaborated strategy across matrix organization for product launch / retirement, inventory balancing, cold chain, elimination of back orders, and expiry reduction for Class II and Class III medical devices in the Structural Heart division with partners in USA, Europe and Costa Rica.• Led implementation of Supply Chain processes (Planning and Scheduling) for the Murrieta facility. Completed implementation 2 months early.• Designed and implemented Rough Cut Capacity Planning process and tools in order to provide centralized capacity planning data/analysis to 7 shared services organizations.• Coordinated strategy for product launch / retirement, inventory balancing, cold chain, elimination of back orders, and expiry reduction for Class II and Class III medical devices.• Planned and facilitated Best Practices Workshop for Supply Chain Management teams in 7 business units across four countries.• Responsible for development of custom scheduling database, consolidating schedules of multiple guidewire production lines to provide single schedule for upstream sub assembly area (Access, SQL, VB, Excel)• Responsible for leading a manufacturing team through the development and implementation of a scheduling process to replace the inventory-heavy KANBAN system.• Identified need and implemented process to track R&D absorption vs non-absorption units for financial forecasts / planning in a cost accounting environment resulting in more accurate financial planning (SAP).

• Management of multiple production lines and up to 120 direct reports for Class II and Class III medical devices.• P & L responsibility.• Created micro-business-management teams for each production line in the Endovascular Operations division. Resulted in increased cohesion in goals and focus. Improved ability to achieve target inventory levels and Cost Improvement Projects.• Multiple LEAN implementations (5 projects / manufacturing lines) driving productivity improvements from 10 – 41% per project.• Project management across multiple business units / countries.

•Lead a cross-functional team to drive culture change and decrease cost by $1.5MM annually. •Coordinated cross functional efforts across 4 business units, in 6 facilities, in USA, Puerto Rico, Ireland and Costa Rica to develop a single process that was approved by consensus of 30 individuals.

Provide supervision for 50+ employees and team leads in the manufacture of medical devices.

• Responsible for completing a leveraged-buy-out acquisition of a small business. • Managed all P&L responsibilities. • Implemented new CRM software and financial software. • Developed marketing campaigns • Developed metrics to track productivity of employees. • Created procedures to ensure consistent operations performance.

Taught Marketing, Sales and Management courses in on-site and remote formats.