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Détails du poste

Company Profile: 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 · Strong understanding of project management, 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. · Knowledge of SolidWorks (and PDM) CAD software (Advantage)

Ce que vous ferez

The role involves defining project scopes and leading engineering changes through CR/DCR/DCN processes to transfer approved changes into production. The engineer will also develop manufacturing processes, support equipment qualification, and identify opportunities for efficiency and quality improvement.

Exigences

Candidates must have a Bachelor's degree in Mechanical, Biomedical, or a related engineering field with over 3 years of experience in medical device manufacturing. Proficiency in SolidWorks and familiarity with medical device quality standards like ISO 13485 are highly valued.

Compétences indiquées

• Gestion de projet · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Project Management
• Manufacturing Engineering
• NPI Principles
• ISO 13485
• FDA Regulations
• SolidWorks
• PFMEA
• Process Validation
• IQ/OQ/PQ
• Root Cause Analysis
• Technical Writing
• Cross-functional Collaboration

Domaines d’emploi

• Engineering
• Manufacturing
• Healthcare
• Science & Research