Job Description

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.

Department: Manufacturing
Site: 3505 Laird Road, Mississauga, Ontario. Moderate travel (10% - 30%) is expected.
Reports to: Manufacturing Engineering and Service Manager
Hours: 37.5 hours per week
Status: Permanent Full-time
Closing Date: September 22nd, 2025
Duties and Responsibilities:
Engineering and Manufacturing Support:

• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure successful manufacturing operations.
• Participate in the design and optimization of manufacturing processes, workflows, and assembly methods to improve efficiency, reduce costs, and enhance product quality.
• Design and develop manufacturing jigs, fixtures, and tooling to aid in the assembly and testing of medical devices.
• Monitor production lines, identify potential bottlenecks or issues, and implement corrective actions as needed.
• Assist in the creation and maintenance of manufacturing work instructions, standard operating procedures (SOPs), and documentation.

New Product Introduction (NPI):

• Contribute to the NPI process by providing engineering expertise in the evaluation of new designs, prototypes, and components.
• Collaborate with R&D and design teams to ensure seamless transfer of products from development to production.
• Support the validation and verification activities for new products, ensuring they meet regulatory requirements and quality standards.
• Write IQ/OQ/PQ and execute new equipment validation and verification.
• Creating manufacturing process maps and process failure mode and affect analysis (PFMEA).
• Participate in risk assessment and mitigation strategies during the NPI phase.

Client Equipment Field Servicing:

• Act as a technical resource for clients by providing on-site servicing and maintenance of medical equipment, ensuring optimal performance and adherence to manufacturer specifications.
• Troubleshoot and diagnose technical issues related to medical devices, utilizing problem-solving skills and technical knowledge to resolve issues promptly.
• Conduct routine preventive maintenance and calibration of medical equipment at client locations.
• Train clients on proper usage, maintenance, and troubleshooting of equipment to ensure safe and effective operation.

Continuous Improvement:

• Identify opportunities for process improvement, quality enhancement, and cost reduction within manufacturing and servicing activities.
• Actively participate in root cause analysis and corrective action implementation for any identified issues.

Documentation and Compliance:

• Maintain accurate and up-to-date records of all manufacturing, NPI, and servicing activities, ensuring compliance with regulatory requirements.
• Contribute to the preparation of technical reports, performance summaries, and documentation for regulatory submissions.

Qualifications

• Bachelor's degree in engineering (Mechanical, Biomedical, or related field).
• 3-5 years of experience in manufacturing engineering and field servicing, ideally in medical devices.
• Strong understanding of manufacturing processes, quality standards, and NPI principles.
• Familiarity with medical device regulations (FDA, ISO 13485) and quality management systems.
• Excellent problem-solving skills and ability to troubleshoot technical issues.
• Effective communication and interpersonal skills for cross-functional collaboration and client interactions.
• Willingness to travel to client sites for equipment servicing (estimated 10-30% travel).
• Knowledge of SolidWorks (and PDM) CAD software.
• Knowledge in creating manufacturing process maps and process failure mode and affect analysis (PFMEA).
• Basic programming skills for equipment calibration and diagnostics.

Skills Required