Assumed the responsibilities and tasks associated with Design Verification to Product Release to Market. Established the Project Plan and testing strategy, working with multiple suppliers to ensure timely component availability, worked with the contract manufacturer to develop an efficient team to ensure project success. Key responsibilities included: Developing the project plan, managing resources, and achieving milestones. Engaging with stakeholders for requirement gathering and regular updates. Identifying risks and implementing mitigation strategies. Ensuring quality assurance and compliance with standards.

• Worked remotely conducting a GAP Analysis of electrical, electronic, and packaging materials in preparation for the transition from RoHS 2 (Directive 2011/65/EU) to RoHS 2 Directive (EU) 2015/863. • Communicated with various suppliers to obtain an RoHS 2 Directive (EU) 2015/863 Environmental Declarations of Conformity.• Organized Gap Analysis information into a summary for presentation to the Notified Body.

• Worked remotely to update Engineering Documentation for the Aortic Valve Graft (AVG) and Delivery System to meet P&F Products quality standards and cGMP. • Investigated, corrected, and provided responses to a notified body Quality Systems Audit. • Improved AVG & Delivery System assembly procedures to include pictures, and detailed steps, addition of in-process Operator Self Inspections, identified and separated processes to improved process flow.• Conducted GAP Analysis of assembly documentation to the pFMEA. Created all documentation to effectively update the pFMEA by adding missing process steps, potential failure modes, causes, and effects.

• Conducted an audit of the Quality Management System ensuring compliance with both FDA and ISO 13485 Guidelines & Standards. • Provided a detailed report with recommendations for improvement along with a proposal and timeline for remediation.• Transitioned from Auditor to Remediator role and began investigating, documenting, and implementing improvements for compliance to QSR's.

• Designed and developed medical device labelling to ensure compliance with quality and regulatory requirements of both FDA and ISO. • Project Lead ensuring all design control and regulatory activities required for the release of the PreserFloTM MicroShunt to new international markets are met. • Investigated and closed several CAPA’s. • Provided Engineering support for multiple projects. • Supported the development, validation, and implementation of UDI Barcoding for all product labelling.

• Assisted in the development and improvement of the manufacturing and inspection processes for the Proximal Embolic Device & Delivery System. • Developed and implemented an MS Excel based inventory control system for a pilot line and low volume production.• Project Lead and System Administrator for the implementation of SAP Business One ERP System. • Developed procedures and trained personnel to use SAP Business One. • Authored and conducted software validation of SAP Business One.• Established Returned Goods Lab and associated operating procedures.

• Founding member of the company, responsible for facility layout, equipment, and EM Room selection, installation, and validation. • Responsible for the company’s day to day operations including manufacturing, supply chain, engineering, facilities and warehousing. • Successfully registered the facility with FDA.• Authored, submitted, and gained clearance on two 510(k) Applications, • Authored all device assembly instructions and inspection procedures, conducted training, wrote and participated in the execution of equipment and process validation protocols & reports. • Managed 15 Team Members.

• Conducted Management Reviews, Design Reviews, supplier, and system audits. • Provided day-to-day business leadership and management as part of the Senior Leadership Team, supported Supplier selection, evaluation, and approval. • Developed and installed the Quality System ensuring compliance with FDA & ISO Regulations & Guidelines. • Authored protocols & reports to support product, process, and test method validation. • Developed written test methods based on ISO Standards and supported tool and fixture development.

• Responsible for manufacturing compliance and collaborating with the Production Quality Control Supervisor to improve and streamline manufacturing & quality processes. • Investigated and closed Non-Conforming Material Reports, Corrective Action / Preventive Action Reports, and Supplier Corrective Action Reports.

• Developed, implemented, and managed the Quality and Documentation Control Systems in compliance with FDA & ISO Regulations & Guidelines.

• Developed, implemented, and managed the Quality and Documentation Control Systems in compliance with FDA & ISO Regulations & Guidelines.

• Selected the facility for startup operations. • Team Member for the development and implementation of a Lean Culture throughout the organization, • Project Leader for the Flexible Endoscopic Scissors project • Responsible for process refinement, test method development, implementation, validation, and introduction into the production environment. • Managed the planning, proposals, and expansion from Pilot to Product Manufacturing Areas from 500 sq. ft. to 2,000 sq. ft.

• Conducted and participated in Management Reviews, Design Reviews, Supplier, and Internal Audits. • Created and implemented the Apollo Receiving Inspection department. • Worked closely with R&D Engineers to develop adequate Inspection requirements based on risk and assembly / functionality specifications. • Supported the validation, and implementation of cloud–based Quality Management System software.

• Production, Purchasing, and Facilities Management - Coordinated the transfer of the InfusionCath & ErgoCath from R&D to Production; wrote Product Validation Protocols & Reports; organized purchasing, production, and material inspection scheduling activities to align with the product build schedule, successfully led the Manufacturing, Purchasing, and Facilities Departments through the ISO 13485 Surveillance Audit, ensured VeinRx facilities were properly maintained to meet County Fire & Safety Codes as well as comply with cGMP and internal safety requirements.

• Responsible for compliance with design control procedures; set up of Pilot Manufacturing; instrumental in the process development, aided in the development of assembly instructions and quality inspection procedures.

• Worked onsite to assess and debug a customized MS Access database designed to track and report data gathered from clinical studies. • Authored and conducted the Software Requirements Specification, Database Process Flowchart, and a Backup / Restoration procedures, Validation Protocols and Reports.

• Reviewed, investigated, and approved Material Review Records (MRR) for the Self-Expanding Stent Department, assisted the New Product Development Team by reviewing, editing, and approving Tool Master Records, Tool Validation Protocols, and Validation Reports.

• Assigned to investigate and determine root cause(s) of Receiving Inspection failures related OEM Catheter balloon catheters; organized, opened, and investigated MRR’s for defects; reduced the number of open MRR’s from 100+ to less than 20 as well as reduced the time to close from 3 months down to 4 days; implemented a defect verification procedure resulting in a significant reduction in MRR’s created. • Participated in the negotiation for the return of defective materials to supplier resulting in $2M customer credit.

• Project Lead for the transfer of the Commisuratome Percutaneous Mitral Valvuloplasty device into the Bolton Medical portfolio of devices. • Created project plan, updated manufacturing, and inspection documentation, assessed, and updated component drawings, sourced local suppliers, and initiated the development of the assembly line.

• Recommended, installed, and qualified a thermal transfer label printing system, labelling software, and materials. • Created material specifications, standard operating procedures, quality inspection procedures, and IQ/OQ/PQ Protocols and Reports to support the implementation and production use of the new labelling system.

• Lead Process Development Engineer for the Talent Abdominal Aortic Delivery System (ADS); implemented single piece flow production line; redesigned critical bonds for the Talent ADS resulting in a 75% increase in production throughput, and the successful completion of a 3-year accelerated shelf-life validation.• Manufacturing Engineer: Investigated and responded to customer complaints resulting in internal and supplier corrective actions.• Production Lead Supervisor: First Shift Supervisor responsible for collaboration with Quality, Customer Service, and Second Shift Production; Coordinated hiring and training of new employees for expansion of a second assembly line; Served as Manufacturing Team Leader preparing for an ISO Surveillance Audit.• Project Manufacturing Engineer: Investigated Customer Complaints for balloon leaks; redesigned and validated a new delivery system balloon attachment method resulting in zero customer complaints for balloon leaks; Redesigned the Delivery System Production Cell and Stent Graft Assembly Lines resulting in the ability to consistently meet production demand.

• Manufacturing representative assigned to the TrufillTM Embolic Coil project.• Developed Manufacturing Instructions; transferred product from R&D to pilot production; supervised and trained all operators; performed the IQ, OQ, and PQ on the Pilot Line; transitioned the line to full production.

• Created project timelines, sourced materials, designed and developed EtO compatible packaging to meet Design and Marketing inputs. • Worked closely with product development and manufacturing engineering to ensure any changes to the product design or manufacturing areas were captured throughout the project and supported product & process validations.• Certified Maintenance Tech.; maintained and repaired 40+ Zebra Printers; developed and implemented an Operator Training/Maintenance Program and Troubleshooting Reference Guide; trained Lead Operators resulting in 25% reduction in printer down time.