Greater Toronto Area, Canada
Worked in large Fortune 100 companies, medical start up companies, and supported integration within Fortune 500 companies. Led teams of more than 10 individuals working in Planning, Purchasing, Receiving, Stockroom, Production, Facilities, Quality Control, and Manufacturing Engineering. • Built out manufacturing operations from the ground up at early stage start ups. • Focused manufacturing operations on core values and competencies; drove outsourcing activities. • Increased manufacturing capacity to support forecasted revenue growths. • Managed the budget of manufacturing operations, planned staff growth, and reduced overall product costs. • Supervised and worked in manufacturing operations under FDA regulations for medical devices. • Drove quality program development for internal quality audits and FDA inspections. • Implemented metrics to track the status of manufacturing and Pareto defects to improve yields. • Served as a Corporate and Site Lean Leader to drive Kaizen events to improve manufacturing processes. • Actively involved in joint health and safety committees to ensure manufacturing site compliance.
Medical device start-up company developing technologies to guide minimally-invasive procedures by miniaturizing imaging systems to be introduced into the body. Hired into the organization to build out a catheter manufacturing facility and team to support the company from research and development through product transfer into production. • Oversaw facilitates within manufacturing, completed improvement projects of facilities, maintained a clean room, and supported day to day issues. • Developed hiring plans and staffed manufacturing using internal HR team, including manufacturing process engineers, buyers, quality control positions, and production technicians. Team grew from 4 employees to over 30 employees in 3 years. • Supported pre-production builds of capital equipment at a contract manufacturer and completed a project to transfer production of capital equipment to Conavi. • Created the supplier management process for suppliers and performed audits of high risk suppliers. • Initiated resourcing to focus supply base within Canada. • Drove the utilization of the existing Fishbowl MRP system and investigated the implantation of an ERP system. • Worked with quality team and authored required SOPs for compliance to ISO13485 and FDA 21 CFR 820. • Interfaced regularly with R&D team to drive improvements to existing processes and products during transfer to manufacturing.
In vitro diagnostics startup focusing on delivering a market changing multiplexed point of care system. Hired into the organization to build out a manufacturing facility to support the company from research and development through the clinical and analytical trials of the product. • Facilitated site preparation, completed orders of remaining equipment, installed a clean room, and setup site. • Staffed manufacturing using an external recruiter, including manufacturing process engineer, senior materials manager, quality control, and production technicians. • Worked with quality team and authored required SOPs for planned ISO13485 certification of manufacturing. • Initiated relationships with suppliers and procured materials to support research and development builds. • Planned and supported manufacturing staff in the documentation of processes and equipment. • Implemented metrics to track the status of manufacturing to support communication to Senior Management. • Engaged new suppliers and existing supply base to focus manufacturing operations on value added operations. • Worked with research and development team on design for manufacturing of the current product and to reduce overall product cost. • Developed plans, engaged with automation suppliers, and budgeted to scale-up manufacturing.
Leading global woman's healthcare company producing a suite of high-end MRI coils, patient stretchers and software solutions for GE, Toshiba, and Siemens; providing a fully integrated breast imaging system that results in the highest quality of patient care. Ran site’s manufacturing operations; added facilities and environmental heath and safety responsibilities after head count reductions. Negotiated contracts with facility service providers and ensured day to day operations of the Toronto facility. Led environmental health and safety program and initiated compliance to ISO 14001. Focused manufacturing team to reduce inventory levels, improve part availability, and drive improvements in manufacturing processes. Served as Corporate Lean Leader of Hologic while that individual was on maternity leave for 6 months and led Kaizen event in the Danbury CT facility to improve the final configuration of the mammography systems. Implemented a “My CI” continuous improvement system to support future site roll-outs within Hologic. Scheduled Kaizen event every quarter.
Led stockroom, shipping, receiving, planning, procurement, production, manufacturing engineering, and quality control departments. Managed the budget for the Toronto manufacturing operations. Created detailed goals and objectives to drive improvements across the manufacturing team. Focused manufacturing operation on the core competency of assembling and tuning coils. Analyzed and initiated an outsourcing initiative to move non core processes to contract manufacturers. Drove the continued development of the quality system in manufacturing to pass FDA inspections. Led corporate Kaizen team to consolidate all manufacturing operations onto a single floor; previously manufacturing operations were spread over 3 floors. Supported site financial objectives through manufacturing headcount reductions due to missed sales forecasts.
Combined mechanical and electrical manufacturing engineering teams. Supported transition of Sentinelle into Hologic; transitioned the ERP software to Oracle on the manufacturing floor and adopted Agile for manufacturing and quality control documentation. Utilized these tools and systems to lay the foundation to develop detailed manufacturing processes and built a robust quality system on the manufacturing floor. Led team of manufacturing engineers and continued to support the introduction of new products into manufacturing through cross-functional teams. Embraced the position of Toronto Site Lean Champion and started training all manufacturing employees on Lean.