Mississauga, Ontario, Canada
Manufacturing Engineer with 7+ years of experience in process development, New Product Introduction (NPI), and manufacturing engineering across medical device and industrial manufacturing environments. Experienced in process validation (IQ/OQ/PQ), verification and validation (V&V), PFMEA, CAPA, NCR, and engineering change management within FDA, ISO 13485, and GMP regulated environments. Strong background in collaborating with cross-functional teams to develop efficient manufacturing processes, support product transfers from design to production, and drive continuous process improvements. Technical expertise includes SolidWorks, PLC programming, automation systems, Lean Manufacturing, Six Sigma, root cause analysis, and manufacturing documentation.
•Lead end-to-end engineering projects from concept through validation and production. •Develop and manage project plans, timelines, milestones, and deliverables to ensure on-time execution. •Collaborate with cross-functional teams (R&D, Manufacturing, Quality, Supply Chain) for successful NPI and product transfer. •Serve as the primary interface between customers, suppliers, and internal stakeholders. •Drive technical problem-solving using data-driven and risk-based approaches. •Manage project budgets, cost estimation, and resource planning. •Identify and mitigate risks through tools like PFMEA while driving continuous improvement initiatives. •Ensure compliance with FDA, ISO 13485, and GMP standards in process development and documentation. •Oversee supplier performance and implement corrective actions to meet project requirements. •Coordinate prototype builds, testing, and validation to ensure product readiness for manufacturing. •Develop and maintain manufacturing documentation, process maps, and change management records.
-Researching, planning, and evaluating designs for multiple projects while tracking their development from the stage of conception to the end of its life cycle. -Analysing project scope to determine material requirements, process capabilities and provide related technical specifications/ clearly defined work instructions. -Coordinated resource planning and helped resolve internal technical issues through problem identification and performing root cause analysis, to ensure minimal production impact. -Responsible for creating design specifications, maintaining BOM using ERP, updating technical information, and associated engineering change documentation for supporting production activities. -Applying Six Sigma (DMAIC) methodology to projects throughout the industry, to identify the gaps in the process and ensure that the project deliverables are met continuously. -Optimized project efficiency and streamlined lean manufacturing processes through proper implementation of Kanban boards, 5S, and Kaizen techniques. -Supporting the manufacturing shop activities through developing CNC part programmes and the ability to operate both manual and automated CNC machine tools. -Performed routine maintenance activities on CNC machines and/or associated tools, to ensure superior quality, while accounting for repeatability. -Implemented project schedule and managed production-related activities to ensure that projects are delivered on time while tracking progress at each stage. -Performing any other functions for the machine shop as required.
-Develop, manage, and review shop floor or production cell drawings. -Calculate TAKT time and forecast future projects to ensure zero downtime on machines. -Provide technical support for manufacturing of newly introduced parts and reviewing pilot production. -Participate in established continuous improvement processes (Kaizen, DMS) and make recommendations. -Conducted spot inspections and prepared a progress report weekly to present to the senior engineers.
-Updating and maintaining all engineering records, Bills of Materials using ERP, ensuring document change control, reviewing product acceptance reports to incorporate essential customer feedbacks. -Developing process plans to ensure uninterrupted process flow throughout the cycle and maintaining effective schedules for job completion, facilitating on time delivery of all products. -Collaborating with cross functional teams for reviewing material and equipment requirements or availability and working towards resolving any nonconformance that may arise during the design or manufacturing process. -Introduced the concept of monitoring Key Performance Indicators (KPI) to maintain the desired level of quality standards throughout the manufacturing process ensuring higher precision and accounting for repeatability.