Customer liaison. Site development. Training plans. Commissioning of new installations. Continuous Improvement.

• Led the successful qualification of six multi-cavity injection molds and Factory and Site Acceptance Tests for 3 automation lines, ensuring all validation activities complied with relevant regulatory standards, such as Good Manufacturing Practices (GMP), and ISO 13485. • Developed and executed validation test plans for Class II assembly line validations, including IQ/OQ and PQ phases. Provided capacity to produce COVID sample collection kits during the pandemic, meeting targeted inventory levels resulting in increased sales.• Led the transfer and validation of six injection molding tools to key supplier to resulting in cost reduction and improved quality.• Supported the launch of new products, working with multiple internal and external partners to ensure continuity of supply, customer satisfaction, and adherence to all quality standards for the large-scale manufacture of medical devices. • Supervised Factory and Site Acceptance Tests for automation lines, developed FMEAs, and supported CAPAs and deviations to meet aggressive timelines for product availability.• Led scientific molding studies to develop the process for capable production runs.• Managed the decommissioning and storage of production lines per ISO-13486.

• Championed the implementation of two-shot molding reducing cartridge components from 5 to 1, resulting in cost savings of 35%, quality improvements, increased manufacturing output and simplified supply chain. • Recognized as Subject Matter Expert on injection molding supplier tooling. Established processes and monitoring systems to validate over $9.4M in injection molding tools.• Drove the qualification of new injection molding tools providing technical expertise in developing validation plans and reports, User Requirements and risk assessments (e.g. FMEA and DFMEA).• Maintained project controls and reporting mechanisms for validation scope, cost and schedule throughout the development cycle from part design, material selection, mold development to process and product validation.• Improved quality across components by partnering with suppliers using advanced injection molding technologies and SPC.• Reduced cost and improved quality and supply by identifying, recommending, and implementing design changes; validating alternate suppliers, new tooling, new processes and new materials for components used in cartridge assembly to reduce costs, drive up quality and improve supply.• Drove sustainable corrective and preventative actions to align with Critical Quality Attributes that improved product quality.• Implemented best practices with advancements in technology and material by developing partnerships with suppliers identified at industry trade shows.• Reviewed product performance, determining component impact and implemented engineering changes that resulted in a repeatable process and consistency of supply.• Actively participated in Abbott Injection Molding Best Practices Group, providing expertise on validation of products and processes, including guidance on strategy, risk mitigation and Design for Manufacture, creating corporate standards.• Partnered with Senior Leadership on progress, deliverables and supply, ensuring key milestones were met.

Spearheaded the design, prototyping, testing and validation of ruggedized magnetic wheel speed sensors for the commercial aerospace and defense marketsConducted environmental, high & low temperature (200 °C to -65 °C), vibration, and acceleration tests; also partnered with the National Research Council (NRC) Canada on tests in their Explosion laboratory in OttawaLed the development of endurance test equipment, data acquisition and motion control and environmental test chamber for qualification testingExecuted vibration testing of designs per Radio Technical Commission for Aeronautics DO-160 at Canadian Space Agency facilities; and led FMEA for various wheel speed sensors