Process Engineer

BITS Recruiting; Quinte West; On-site; CAD 70,000 - 110,000; Full time

Job summary

BITS Recruiting in Trenton, Ontario, is seeking an experienced Process Engineer to join our team. The role focuses on improving production efficiency, product quality, and process capability while supporting new processes and product launches.

Responsibilities include PFMEA, process validation (IQ/OQ/PQ) per ISO 13485, and supporting automation, robotics, and line enhancements. CAD expertise with AutoCAD/SolidWorks, data analysis, and SPC are valued assets for this position.

Qualifications

• Bachelor's degree in engineering required.
• Experience in process engineering, manufacturing systems development, and new program implementation.
• Experience with GMP and GDP; experience with process validation and ISO 13485 is a plus.
• Proficiency in AutoCAD; SolidWorks preferred; strong CAD/documentation skills.
• Strong data analysis, SPC knowledge, and process optimization.

Responsibilities

• Analyze and improve manufacturing processes, process flow, productivity, throughput, and overall equipment effectiveness (OEE).
• Develop and maintain process standards, tooling plans, equipment requirements, and process documentation.
• Conduct PFMEA to identify and mitigate process risks.
• Lead and support process improvement trials, equipment validations, and continuous improvement initiatives.
• Perform equipment and process validation activities per ISO 13485 (IQ/OQ/PQ).
• Support automation, robotics, production line enhancements, and new product development initiatives.
• Participate in 8D problem-solving, root-cause analysis, and corrective actions.
• Develop and maintain technical drawings, tooling docs, equipment layouts, and manufacturing specs in CAD.
• Analyze production data and implement improvement strategies to optimize process performance.
• Support ergonomics, workplace safety, and manufacturing process improvements while ensuring compliance.

Skills

Process optimization

Data analysis

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in Engineering

Tools

AutoCAD

SolidWorks

MS Office

Visio

Minitab

SPC

Job description

We are seeking an experienced Process Engineer to join our team in Trenton. The ideal candidate will bring strong manufacturing and process engineering experience, with the ability to improve production efficiency, product quality, process capability, and cost effectiveness while supporting the development and launch of new processes.

Key Responsibilities

• Analyze and improve manufacturing processes, process flow, productivity, throughput, and overall equipment effectiveness (OEE).
• Develop and maintain process standards, tooling plans, equipment requirements, and process documentation.
• Conduct Process Failure Mode and Effects Analysis (PFMEA) to identify and mitigate process risks.
• Lead and support process improvement trials, equipment validations, and continuous improvement initiatives.
• Perform equipment and process validation activities in accordance with ISO 13485 requirements, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance/Product Qualification (PQ).
• Support automation, robotics, production line enhancements, and new product development initiatives.
• Participate in 8D problem-solving activities, root cause analysis, and corrective actions to prevent recurring issues.
• Develop and maintain technical drawings, tooling documentation, equipment layouts, and manufacturing specifications using CAD software.
• Analyze production data and implement improvement strategies to optimize process performance.
• Support ergonomics, workplace safety, and manufacturing process improvements while ensuring compliance with company policies and procedures.

Qualifications and Requirements

• Bachelor's degree in Engineering.
• Experience in process engineering, manufacturing systems development, and new program implementation.
• Knowledge of process development, safe manufacturing processes, and facility design.
• Experience with process validation, GMP, and GDP.
• Proficiency in AutoCAD; SolidWorks 3D experience is preferred.
• Experience with Microsoft Office applications, including Word, Excel, PowerPoint, Access, and Visio.
• Knowledge of Minitab, Statistical Process Control (SPC), process optimization, and troubleshooting.
• Experience with plastics materials and extrusion processing is an asset.
• Experience implementing automation and robotics solutions is an asset.

AI-enabled tools may be used to sort applications based on job-related criteria. All AI generated results are vetted by our team and the decision of which candidates move forward is always made by a human.

If you have a strong background in process engineering and enjoy improving manufacturing operations, we encourage you to apply!