Engineering Associate II — Process Improvement & Validation

Southmedic; Barrie; Hybrid; CAD 60,000 - 75,000; Full time

Benefits offered by this job

Competitive base salary with bonuses

Mileage & Expenses Reimbursement

RRSP retirement match

Benefits: medical, dental, vision

Education reimbursement

Engagement activities

Job summary

Southmedic is seeking a T2 Engineering Associate in Barrie, Ontario. You will support manufacturing processes, product launches, and engineering change activities, collaborating with Engineering, Operations, Quality, Regulatory Affairs, and PM teams.

You will gain experience in engineering documentation, process validation, risk management, equipment implementation, and project coordination while helping ensure products meet high quality standards and compliance.

Qualifications

• Post-secondary education in Engineering completed or expected within the next 12 months.
• Proficiency with Microsoft Office applications.
• Strong organizational, analytical, and problem-solving skills.
• Excellent attention to detail and documentation skills.
• Ability to work independently while contributing positively within a team environment.
• Experience within a regulated manufacturing environment.
• Familiarity with MDSAP and ISO 13485 requirements.
• Project management experience or training.
• Experience using SolidWorks.

Responsibilities

• Create and implement Engineering Change Notices (ECNs).
• Develop and maintain Bills of Materials (BOMs) and Detailed Operator Working Instructions.
• Coordinate training activities for production personnel related to engineering changes.
• Provide support to Engineering team members on departmental initiatives and projects.
• Assist in evaluating, designing, and implementing improvements to manufacturing work cells, tooling, and equipment.
• Create, modify, and maintain technical drawings using SolidWorks.
• Participate in PFMEA, DFMEA, risk management, and validation activities as required.
• Author and support the execution of validation protocols and reports.
• Prepare engineering reports, data analysis, charts, and technical documentation.
• Investigate and recommend manufacturing equipment and process improvement opportunities.
• Provide engineering support to production and maintenance teams.
• Manage customer and internal projects using best project management practices, balancing scope, schedule, and cost.
• Ensure manufacturing documentation is complete and approved prior to product launch.
• Maintain control of customer specifications, ATPs, artwork files, and other controlled documents.
• Partner with Quality and Regulatory Affairs teams to ensure compliance with applicable standards and requirements.
• Manage the open VIAF list and facilitate timely closure of actions.
• Maintain the Engineering Change Notice log and ensure document accuracy.
• Perform dimensional studies and support Measurement Systems Analysis (MSA) activities.
• Provide administrative support to project managers as required.
• Follow all Southmedic policies, procedures, work instructions, and quality system requirements.
• Perform additional duties as assigned

Skills

Microsoft Office

Analytical skills

Attention to detail

Documentation

Team player

Regulated manufacturing

MDSAP / ISO 13485

Project management

SolidWorks

Education

Engineering degree (completed or expected)

Tools

SolidWorks

Job description

Southmedic is seeking a T2 Engineering Associate in Barrie, Ontario. You will support manufacturing processes, product launches, and engineering change activities, collaborating with Engineering, Operations, Quality, Regulatory Affairs, and PM teams.

You will gain experience in engineering documentation, process validation, risk management, equipment implementation, and project coordination while helping ensure products meet high quality standards and compliance.