Senior Manufacturing Engineer
- Mississauga, ON
- On-site
- Posted Oct 9, 2026
- 1 position
$100,000–$120,000 / year
Opens an external site
- Employment type
- Full-time
- Experience level
- Senior · 7+ years
- Minimum education
- Bachelor’s degree
- Posting language
- English
- Working hours
- 40 hours per week
Job summary
The Senior Manufacturing Engineer leads the transfer of new products from development into production while ensuring process robustness and scalability. They provide technical leadership to the team and manage activities such as equipment qualification, process validation, and continuous improvement initiatives.
Job details
Company Description 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. Traferox Technologies Inc. Job Description Union: Non-Union Number of vacancies: 1 New or Replacement Position: New Site: 2400 Skymark Ave unit 3, Mississauga, Ontario L4W 5K5, Canada Department: Manufacturing Reports to: Vice President of Manufacturing and Service Salary Range: $100,000–$120,000 annually Hours: 40 hours per week. Shifts: Monday to Friday (Days) Status: Permanent Full-Time Closing Date: October 21, 2026 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. They will be responsible for developing and optimizing manufacturing processes, tooling, fixtures, and assembly methods to improve efficiency, product quality, and production capacity. 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.
What you’ll do
The Senior Manufacturing Engineer leads the transfer of new products from development into production while ensuring process robustness and scalability. They provide technical leadership to the team and manage activities such as equipment qualification, process validation, and continuous improvement initiatives.
Requirements
Candidates must hold a bachelor's degree in an engineering discipline and possess at least 7 years of experience in a regulated manufacturing environment. Strong expertise in NPI, process validation, and technical documentation is required, along with the ability to mentor junior staff.
Benefits
- Competitive salary
- Professional growth opportunities
Listed skills
- Mentorship · Preferred
- Root Cause Analysis · Preferred
- Lean Manufacturing · Preferred
- Project management · Preferred
- Continuous Improvement · Preferred
Other relevant skills
Identified from the job description. Confirm important requirements above.
- Manufacturing engineering
- NPI
- Process validation
- Technical leadership
- Mentorship
- Root-cause analysis
- Lean manufacturing
- PFMEA
- Equipment qualification
- Medical device manufacturing
- ISO 13485
- Project management
- Technical writing
- CAD
- ERP/MRP systems
- Continuous improvement
- Regulatory Affairs
- Process Validation
- Medical Device Manufacturing
- Technical Issues
- People Management
- Qualification Protocols (IQ/OQ/PQ)
- Process Mapping
- Technical Leadership
- Medical Devices
- Project Delivery
- Data-Driven Decision Making
- Data Analysis
- Technical Support
- Biomedical Engineering
- Corrective And Preventive Action (CAPA)
- Pre-Clinical Development
- Commercialization
- Communication
- Continuous Improvement Process
- Engineering Drawings
- Hepatology
- Scalability
- Innovation
- Interpersonal Communications
- ISO 13485 Standard
- Problem Solving
- Kidneys
- Lean Manufacturing
- Manufacturing Engineering
- Manufacturing Operations
- Manufacturing Processes
- Material Requirements Planning
- New Product Development
- Operations
Job areas
- Manufacturing
- Engineering
- Healthcare
- Management & Leadership
- Manufacturing Engineer
- Manufacturing Engineer (General)
- Industrial and Production Engineers
- Manufacturing Engineers
- Industrial Engineers
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