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APTYX Trenton

Process Engineer (medical device)

Trenton, ON, Canada

Full-time

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Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Apr 6, 2027
Experience: · Has 5 years of relevant professional experience, in the medical device industry and regulatory compliance requirements.
Posting language: English
Posted: Oct 8, 2026

Original job description

At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We make it happen through our integrated, comprehensive capabilities including engineering, molding, extrusion, coatings, and assembly across our global network of 14 manufacturing locations.

To support its growth strategy, Aptyx Trenton is seeking to fill the role of a Process Engineer at our Trenton location. We are looking for an industry experienced individual who will hit the ground running.

Main functions:

The primary function is to ensure the operation's performance integrity and compliance with customer expectations of all products manufactured at Aptyx. The Process Engineer participates in and improves overall efficiency, quality, productivity, and cost of existing processes, as well as being a part of the launch of new processes.

Responsibilities and Duties

Shall use the latest methods of GMP to continually improve throughput and process capability. To accomplish this, the Manufacturing Engineer will use the following Engineering disciplines:

Process Flow and Process Flow Analysis
Tooling Planning, Acquisition and Maintenance
PFMEA to establish process risk of failure
Develop core process standards and drive toward process optimization
Participate in OEE and Capacity Improvement Teams. Conduct trials in support of process improvement. Conduct Validation evaluations on equipment and machinery according to ISO 13485 regulatory requirements. This would include analyzing key data from a run and assembling an improvement strategy for the next run.
Automation and Robotics development for line enhancement and New product development
Participate in 8D and other problem-solving events. To preserve the outcome of the 8D team, update the process documentation to prevent a recurrence.
Help to create and maintain tooling and machine drawings in an organized way. Draft, layout, and specify technical devices, parts, and equipment by providing documentation, detailed instructions, drawings, or specifications to define for others how devices, equipment, or structures are to be manufactured, assembled, modified, maintained, or used.
Troubleshoot process issues and understand the root cause of problems to identify improvement opportunities.
Participate in Ergonomics and safety improvement teams.
Be role models in support of company objectives, policy and procedures and safety guidelines.

Employment and Educational Requirements:

· Embrace high-performance team principles

· BSc in Engineering with experience in new program/systems development.

· Has 5 years of relevant professional experience, in the medical device industry and regulatory compliance requirements.

· Experience in Plastics materials & extrusion processing is an asset.

· Process development, safe manufacturing processes, and facility design (AutoCAD preferably SolidWorks 3D)

· Process validation; Installation Qualification (IQ), Operational Qualification (OP), and Product Qualification (PQ)

· Good Manufacturing Practices (GMP), Good Documentation Practices (GDP).

· Microsoft Office; Word, Excel, PowerPoint, Access, and Visio.

· Optimize and troubleshoot systems.

· Minitab Software and Statistical Process Control.

Competency Profile

Self-motivated, safety motivated, continuous learner, and highly organized with the ability to manage multiple and concurrent priorities.
Excellent interpersonal skills, professional attitude, and the ability to interact with various individuals and present information effectively to an audience of various technical backgrounds.
Automation & Robotics implementation experience
Advanced negotiation skills, analytical, and problem-solving abilities.
Data driver, customer-oriented, and not reluctant to take the lead.
Excellent influencing and decision-making abilities.
Results-oriented with the ability to balance other business and departmental strategic goals and objectives with their own.

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More about this job

Responsibilities

Improve the efficiency, quality, productivity, and cost of existing manufacturing processes, and support the launch of new processes. Conduct process trials and validations, troubleshoot issues, support automation and continuous improvement initiatives, and maintain process documentation and technical drawings.

Requirements

Requires a bachelor's degree in engineering and five years of relevant experience, including medical device industry and regulatory compliance experience. Candidates should have knowledge of process validation, GMP and GDP, process development, statistical process control, and troubleshooting; plastics and extrusion experience and AutoCAD or SolidWorks skills are assets.

Skills

Process Engineering
Medical Device Manufacturing
Process Improvement
Good Manufacturing Practices
Process Validation
PFMEA
Statistical Process Control
Minitab
Plastics Processing
Extrusion
Automation and Robotics
Root Cause Analysis
Problem-Solving
AutoCAD
SolidWorks
ISO 13485 Compliance

Visa sponsorship

Not detected in the job text

Keywords

Process Engineering
Medical Devices
Manufacturing
ISO 13485
Good Manufacturing Practices
Good Documentation Practices
Process Validation
Installation Qualification
Operational Qualification
Product Qualification
PFMEA
8D Problem Solving
Overall Equipment Effectiveness
Capacity Improvement
Process Flow Analysis
Tooling
Plastics Materials
Extrusion Processing
Automation
Robotics
AutoCAD
SolidWorks
Minitab
Statistical Process Control
Root Cause Analysis
Ergonomics
Safety
Microsoft Office
Process Optimization

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