Manufacturing and Service Engineer

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

Department:
Manufacturing

Reports to:
Manufacturing Engineering & Service Manager

Status:
Permanent Full-time

Location:
The work will be performed in the company's place of work at 3505 Laird Rd. Unit 16, Mississauga, Ontario. Moderate travel (10 – 25%) is expected.

Duties & Responsibilities:

• Analyze manufacturing processes to identify areas for improvement in efficiency, quality, and cost-effectiveness.
• Develop and implement strategies to optimize production workflows, minimize downtime, and enhance overall manufacturing performance.
• Developing new and improving existing manufacturing processes maps (PMAPs) and (PFMEAs) and Production qualification plans.
• Utilize SolidWorks CAD software and engineering principles to design and develop mechanical components and assemblies for manufacturing and test jigs and fixtures.
• Conduct feasibility studies and performance analyses to ensure design integrity, functionality, and manufacturability.
• Collaborate with R&D and production teams to optimize designs for manufacturing efficiency, cost-effectiveness, and reliability.
• Establish and maintain quality standards and procedures in accordance with regulatory requirements and industry best practices.
• Verification and Validation of new equipment and of new processes.
• Conduct IQ/OQ/PQ to qualify new JIGs/equipment.
• Provide technical assistance to internal teams and external partners regarding product specifications, assembly procedures, and troubleshooting.
• Respond to customer inquiries and service requests in a timely and professional manner, addressing technical issues and providing solutions to ensure customer satisfaction.
• Travel to customer site to perform preventative maintenance work, training, troubleshooting repairs, upgrades and investigations.
• Create and maintain technical documentation, including assembly instructions, troubleshooting guides, and service manuals.
• Conduct training sessions for production staff and service technicians to ensure proper understanding and implementation of manufacturing processes and procedures.

Qualifications

Education:

• Bachelor's degree in engineering, manufacturing, or related field; advanced degree preferred.

Experience:

• 2+ years of experience in medical device manufacturing, with a strong background in production management, quality assurance, and regulatory compliance.

Skills and Knowledge:

• Demonstrated leadership experience, with the ability to effectively lead and motivate teams in a fast-paced manufacturing environment.
• In-depth knowledge of manufacturing processes, quality management systems, and regulatory requirements for medical devices, including FDA regulations and ISO standards.
• Strong analytical skills and problem-solving abilities, with the ability to analyze complex issues, develop practical solutions, and drive results.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, customers, and external partners.
• Proven track record of driving process improvements, cost reductions, and operational efficiencies while maintaining high standards of product quality and customer satisfaction.
• Experience with lean manufacturing principles, Six Sigma, or other continuous improvement methodologies is a plus.
• Familiarity with ERP systems, manufacturing software, and data analysis tools is preferred.
• Ability to travel occasionally to customer sites, suppliers, and other company locations as needed