Senior Manufacturing Engineer

Job summary

Lead manufacturing readiness, new product introduction, design transfer, process development, equipment qualification, and validation through production launch. Improve manufacturing performance and documentation, lead investigations and engineering changes, mentor junior staff, and collaborate with R&D, Quality, Regulatory Affairs, and Operations.

Job details

Company Profile: Traferox creates, manufactures, and commercializes products used for preservation, perfusion, and assessment of solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives. Location: The work will be performed in the company’s place of work at: 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5. Minimal travel <10% is expected. Duties and Responsibilities 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. 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.

What you’ll do

Lead manufacturing readiness, new product introduction, design transfer, process development, equipment qualification, and validation through production launch. Improve manufacturing performance and documentation, lead investigations and engineering changes, mentor junior staff, and collaborate with R&D, Quality, Regulatory Affairs, and Operations.

Requirements

Requires a bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related discipline, plus 7 or more years of manufacturing engineering experience in a regulated industry. Hands-on experience with new product introduction, process validation, and project delivery is required; medical device experience and knowledge of ISO 13485 are preferred.

Listed skills

• Process Optimization · Preferred
• Root Cause Analysis · Preferred
• Lean Manufacturing · Preferred
• Continuous Improvement · Preferred
• Project management · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Manufacturing Process Development
• Process Optimization
• New Product Introduction
• Design Transfer
• Process Validation
• Equipment Qualification
• Root-Cause Analysis
• Corrective And Preventive Actions
• Lean Manufacturing
• Continuous Improvement
• Project Management
• Cross-Functional Collaboration
• Technical Writing
• Manufacturing Data Analysis
• Mentoring
• Medical Device Manufacturing

Job areas

• Manufacturing
• Engineering
• Management & Leadership
• Healthcare