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Traferox Technologies Inc.

Senior Manufacturing Engineer

Mississauga, ON, Canada

Full-time

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Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Apr 4, 2027
Experience: 7+ years of manufacturing engineering experience in medical devices, aerospace, or another regulated industry.
Posting language: English
Posted: Oct 6, 2026

Original job description

Company Profile:

Traferox creates, manufactures, and commercializes products used for preservation, perfusion, and assessment of solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives.

Location:

The work will be performed in the company’s place of work at:

2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5. Minimal travel <10% is expected.

Duties and Responsibilities

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.

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.

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More about this job

Responsibilities

Lead manufacturing readiness, new product introduction, design transfer, process development, equipment qualification, and validation through production launch. Improve manufacturing performance and documentation, lead investigations and engineering changes, mentor junior staff, and collaborate with R&D, Quality, Regulatory Affairs, and Operations.

Requirements

Requires a bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related discipline, plus 7 or more years of manufacturing engineering experience in a regulated industry. Hands-on experience with new product introduction, process validation, and project delivery is required; medical device experience and knowledge of ISO 13485 are preferred.

Skills

Manufacturing Process Development
Process Optimization
New Product Introduction
Design Transfer
Process Validation
Equipment Qualification
Root-Cause Analysis
Corrective And Preventive Actions
Lean Manufacturing
Continuous Improvement
Project Management
Cross-Functional Collaboration
Technical Writing
Manufacturing Data Analysis
Mentoring
Medical Device Manufacturing

Visa sponsorship

Not detected in the job text

Keywords

New Product Introduction
Design Transfer
Manufacturing Readiness
Production Launch
Process Validation
IQ/OQ/PQ
Equipment Qualification
Process Maps
PFMEA
Manufacturing Risk Assessments
Bill Of Materials
Work Instructions
Root-Cause Analysis
Corrective And Preventive Actions
Engineering Change Control
Lean Manufacturing
Continuous Improvement
ISO 13485
Medical Device Manufacturing
Regulatory Affairs
CAD
ERP/MRP Systems
Yield Improvement
Throughput Improvement
Capacity Planning
Scrap Reduction
Rework Reduction
Manufacturability
Production Scalability
Cross-Functional Project Management

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