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.

Location:

The work will be performed in the company’s place of work at 2400 Skymark Ave, Mississauga,

ON, 40121, Canada

Job Title:

Manufacturing Project Engineer

Type:

Full-time

Department:

Manufacturing

Reports to:

Manufacturing Engineering and Service Manager

Duties and Responsibilities

Define project scope, objectives, deliverables, schedules, and milestones.

Prepare and present project and technical updates.

Track progress, risks, mitigation actions, and project completion dates.

Lead engineering changes through CR/DCR/DCN processes and transfer approved changes into production.

Coordinate work across Engineering, Manufacturing, Quality, Supply Chain, Regulatory Affairs, and Service.

Track action items and follow up with assigned owners.

Develop and update manufacturing processes, work instructions, specifications, and technical reports.

Review drawings and other controlled technical documentation.

Plan and support process validation and equipment qualification activities, including IQ/OQ/PQ.





Knowledge in creating manufacturing process maps and process failure mode and effects analysis (PFMEA).

Coordinate prototype builds and production-readiness activities.

Resolve technical issues during development and production.

Identify opportunities to improve manufacturing efficiency, product quality, and cost.

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.

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.

Education, Experience, Skills

Bachelor’s degree in engineering (Mechanical, Biomedical, or related field).

3+ years of experience in manufacturing engineering and field servicing, ideally in medical devices

Solid understanding of project management, manufacturing processes, quality standards, and NPI

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.

Knowledge of SolidWorks (and PDM) CAD software (Advantage)

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📌 Manufacturing Project Engineer (Mississauga)
🏢 Traferox Technologies
📍 Mississauga