Biomedical Engineering Assistant jobs

Southmedic is known globally as an innovative, high-quality Canadian medical device manufacturer. At Southmedic you will enjoy an open-minded culture that fosters individual growth and career development within a dynamic team. Southmedic believes in continually investing in our staff; allowing you to reach your full potential through ongoing training and development. You will engage with a team that values respect, accountability and integrity.

We are looking for a T2 Engineering Associate a skilled individual who will work closely with Engineering, Operations, Quality, Regulatory Affairs, and Project Management teams to support manufacturing processes, product launches, engineering change activities, and continuous improvement initiatives.

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

What You Will Do

• 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

What We Need

• 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.
• Exposure to plastic injection molding processes.
• Experience using SolidWorks.

What We Offer

• Competitive base salary with performance-based bonuses and incentives.
• Mileage & Expenses Reimbursement – for business related travel.
• Retirement Program - Southmedic will match RRSP contributions in our program that employees can begin participating on their first day.
• Benefits - Our group benefit plan covers medical, dental, vision, and other health needs, including our employee assistance program.
• Perks – Southmedic employees enjoy a variety of perks and discounts from local corporate partners like fitness memberships, events, and more!
• Education Reimbursement - Our continuing education program provides financial assistance for training and education courses.
• Engagement - We hold a number of social activities during the year including BBQ's, giveaways, and employee activities.

Salary Range: $60,000 -$75,000

Al may be used as part of the recruitment process. This posting is for an existing vacancy and is actively being recruited for.

Southmedic is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please advise the Human Resources Department.

We thank you for your interest in joining the Southmedic Team!

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