Managed design control and design transfer of new product development and continuous improvement projects. Strategized and collaborated on project deliverables. Developed and managed project schedules, maintained project timelines, and provided progress reports to key stakeholders. Managed design transfer activities with international manufacturing partner. Authored complex technical project documents including product requirements, risk analysis reports, engineering drawings and specifications, test plans and reports, design history files and technical files. Designed product labeling (e.g., Directions for Use, Packaging Labels). Directed and supported development and sustaining processes in compliance with quality system, FDA QSR’s, and ISO 13485 requirements.• Increased sales ($1.8M) by delivering new products every year managing design control process.• Increased international sales ($280K) by writing new and maintaining existing technical files.• 35% reduction in scrap through new equipment and process improvements in catheter tip forming.• Improved design control process by streamlining process for product and process changes.• Kept schedule and performance goals by managing multiple overlapping projects with cross-functional project teams, communicating with stakeholders, and directing team collaboration that assessed issues and developed solutions.• On-time launch of products by coordinating design transfer activities, developing and executing process and equipment validations (IQ / OQ / PQ), designs of experiments, and writing reports for UV cure adhesive bonding, thermoforming operations, device assembly and packaging.

Led new product development and continuous improvement projects from initiation to product launch. Developed project plans and master schedules, assigned and prioritized tasks, maintained project timelines, and provided progress reports to stakeholders. Designed product labeling (e.g., Directions for Use, Packaging Labels). Created and maintained technical project documents including product requirements, engineering drawings and specifications, test plans and reports, and design history files. Managed design transfer activities, pilot runs and manufacturing validations. Directed and supported development and sustaining processes in compliance with quality system, FDA QSR’s, and ISO 13485 requirements. Established and maintained product costs and bills of materials. Mentored less experienced staff.• Consistently delivered 2 new products per year over 5 years by organizing and prioritizing engineering resources.• Increased customer satisfaction by implementing on-going design enhancements.• On-time 510(k) filings by coordinating verification and validation activities, developing and executing test plans, and writing reports.• 20% - 30% reduction in R&D expenses by optimizing test plans.• Kept schedule and performance goals by managing multiple overlapping projects with cross-functional project teams, communicating with stakeholders, and directing team collaboration that assessed issues and developed solutions.• On-time launch of products by coordinating design transfer activities, developing and executing process and equipment validations (IQ / OQ / PQ), designs of experiments, and writing reports for UV cure adhesive bonding, thermoforming operations, device assembly and packaging.

Managed design control program. Developed and executed project plans, assigned and prioritized tasks, maintained project timelines, and provided progress reports to stakeholders. Provided technical support to manufacturing, and sourced and recommended suppliers. Created and maintained requirements documents and engineering specifications. Developed and executed product verifications and validations, and manufacturing process validations.• Contributed $8M in sales through new products in 2006 by developing and implementing 300 products and 9 product families.

Managed design control program. Developed and executed project plans, assigned and prioritized tasks, maintained project timelines, and provided progress reports to stakeholders. Provided technical support to manufacturing, and sourced and recommended suppliers. Created and maintained requirements documents and engineering specifications. Developed and executed product verifications and validations, and manufacturing process validations.• Consistently developed and implemented 20 new products per year by leading all design control projects.• Increased Engineering Change Control (i.e., ECO’s) throughput 30% by coordinating and organizing changes.• Increased customer satisfaction and distribution channels by implementing HIBC bar coding on all products and integrating with ERP system.

Designed stabilization devices and product labeling (e.g., Directions for Use, Packaging Labels). Developed device assembly processes. Developed and executed product verifications and manufacturing process validations. Created engineering drawings and bills of materials (BOM’s). Authored test methods, manufacturing procedures, verification plans and reports.• Consistently developed and implemented 15 new products per year by coordinating and performing verification and validation activities.• Effectively managed IT operations by assuming additional responsibility.

Developed prototype designs. Transferred design concepts to manufacturer. Created and maintained BOM’s. Managed inventory. Sourced materials and components.• United States Patents # 5906206, 5918602, 6109267 – Therapeutic Compression Garments