Senior Manufacturing Engineer in Mississauga

Traferox creates, manufactures and commercializes products used to transplant solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox currently sells the TorEx Lung Perfusion System and the XPort Lung Transport Device. Traferox Technologies is committed to improving the outcomes of organ transplants and to save patients’ lives.

Position Summary

The Senior Manufacturing Engineer is responsible for leading the transfer of new products from development into production while ensuring manufacturing readiness, process robustness, quality, and scalability. This role provides technical leadership and mentorship to junior manufacturing engineers and service technicians, driving continuous improvement across manufacturing operations. The successful candidate will lead new product introductions (NPI), design transfers, equipment qualification, and process validation activities, while collaborating closely with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations.

Duties

• Provide technical guidance and mentor junior manufacturing engineers and service technicians.
• Lead NPI and design transfer through production launch, establishing manufacturing readiness and capacity.
• Develop and improve manufacturing processes, equipment, tooling, fixtures, and assembly methods.
• Lead equipment qualification and process validation, including IQ/OQ/PQ protocols and reports, in collaboration with Quality Assurance.
• Review designs for manufacturability, assembly, serviceability, and production scalability.
• Develop and maintain process maps, PFMEAs, and manufacturing risk assessments.
• Develop and review drawings, work instructions, BOMs, and controlled manufacturing documentation.
• Lead root-cause investigations and manufacturing CAPA activities with Quality Assurance; verify action effectiveness.
• Implement engineering changes (CR/DCR/DCN), assessing impacts on manufacturing, documentation, training, and validation.
• Use manufacturing data to improve yield, throughput, capacity, and cost, and reduce scrap and rework.
• Manage manufacturing engineering projects, including priorities, schedules, risks, and progress reporting.
• Work with R&D, Quality, Regulatory Affairs, and Operations to resolve technical issues and introduce new products.
• Provide hands-on troubleshooting and technical support to production and service teams.

Qualifications

• Education: Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related engineering discipline.
• Experience: 7+ years of manufacturing engineering experience in medical devices, aerospace, or another regulated industry. Medical device experience is preferred. Hands-on experience in NPI, process validation, and project delivery is required.
• Skills and Knowledge: Ability to mentor engineers and technicians, coordinate project activities, and develop into a team lead. Previous people-management experience is an asset. Strong manufacturing process development, optimization, and continuous improvement skills. Excellent root-cause analysis, problem-solving, and data-driven decision-making abilities. Practical knowledge of Lean manufacturing, continuous improvement, and manufacturing data analysis. Ability to interpret engineering drawings, specifications, BOMs, and technical documentation. Strong technical writing, documentation, communication, and interpersonal skills. Ability to lead cross-functional projects. Knowledge of ISO 13485 and medical device manufacturing requirements is preferred. Ability to work independently, manage multiple priorities, and make sound technical decisions. Experience with CAD and ERP/MRP systems is an asset.

Additional Information

What We Offer Opportunity to work at the forefront of organ transplantation innovation. Direct interaction with leading transplant programs across North America. Exposure to clinical development, product commercialization, and medical education. Collaborative, mission-driven environment focused on improving patient outcomes. Competitive salary, benefits, and opportunities for professional growth.