Mechatronics Engineer / Lead

Sonele Inc.; Markham; On-site; CAD 80,000 - 90,000; Full time

Job summary

Sonele Inc. in Markham, Ontario, seeks a Mechatronics Engineer/Lead to drive design, prototyping, testing, and transfer of medical devices from concept to manufacturing.

You will lead multidisciplinary teams across mechanical, electrical, software, and manufacturing disciplines to meet performance, quality, reliability, and regulatory requirements. The role emphasizes technical leadership, hands-on development, and collaboration with Quality, Regulatory, and Manufacturing to ensure robust

Qualifications

• Bachelor's degree in engineering a related field.
• 5+ years in product development for medical devices or similar.
• Strong hands-on electromechanical development experience.
• Proficient with 3D CAD (SolidWorks or equivalent).
• Experience from concept to manufacturing transfer.

Responsibilities

• Lead the engineering design and development of medical device products.
• Translate product requirements and user needs into clear engineering requirements and specifications.
• Develop system architectures integrating mechanical, electrical, electronic, sensing, and motion-control components.
• Lead concept development, feasibility studies, prototyping, testing, and design optimization.
• Design and develop electromechanical assemblies, mechanisms, fixtures, and systems.
• Create and review engineering drawings, CAD models, BOMs, specs, and other docs.
• Identify design risks and develop practical engineering solutions.

Skills

Mechatronics

Project leadership

Cross-functional collaboration

Technical documentation

Electromechanical design

Education

Bachelor's degree in Engineering

Tools

SolidWorks

PCB design

Embedded systems

Job description

About The Role

We are seeking a Mechatronics Engineer / Lead to join our Engineering & R&D team and take a leading technical role in the design, development, prototyping, testing, and commercialization of medical devices. This is a hands-on technical leadership position for an experienced engineer who enjoys solving complex electromechanical problems and working across mechanical, electrical, electronics, software, and manufacturing disciplines. The successful candidate will lead technical development activities from early-stage concepts through detailed design, prototyping, verification and validation, and transfer to manufacturing. You will work closely with Engineering, Manufacturing, Quality, and other cross-functional teams to ensure our products meet performance, quality, reliability, and regulatory requirements.

Key Responsibilities

Medical Device Design & Development

• Lead the engineering design and development of new and existing medical device products.
• Translate product requirements and user needs into clear engineering requirements and technical specifications.
• Develop system architectures and integrate mechanical, electrical, electronic, sensing, and motion-control components.
• Lead concept development, feasibility studies, engineering analysis, prototyping, testing, and design optimization.
• Design and develop electromechanical assemblies, mechanisms, fixtures, and systems.
• Create and review engineering drawings, CAD models, bills of materials, specifications, and other technical documentation.
• Identify design risks and develop practical engineering solutions to complex technical problems.

Prototyping, Testing & Validation

• Build and evaluate prototypes and proof-of-concept systems.
• Develop test plans, test methods, and engineering test procedures.
• Lead design verification and validation activities and analyze test results.
• Troubleshoot product performance, reliability, and system-integration issues.
• Work with Quality and Regulatory teams to ensure development activities are properly documented and meet applicable medical device requirements.
• Support risk management activities, design reviews, and engineering change processes.

Technical Leadership

• Act as the technical lead for assigned medical device development projects.
• Provide technical direction and mentorship to engineers, technicians, and other team members.
• Lead technical discussions and design reviews and help establish engineering priorities.
• Evaluate technical alternatives and make recommendations based on performance, reliability, manufacturability, cost, and project requirements.
• Coordinate technical activities across mechanical, electrical, software, manufacturing, quality, and regulatory functions.
• Take ownership of technical issues and drive them to resolution.

Manufacturing & Product Transfer

• Work closely with Manufacturing and suppliers to ensure designs are practical, reliable, and manufacturable.
• Apply Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
• Support product transfer from R&D to manufacturing.
• Provide engineering support for production issues, process improvements, and product changes.
• Work with external suppliers and contract manufacturers on component and product development when required.

Qualifications

• Bachelor's degree in Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of relevant engineering experience in product development, preferably in medical devices, healthcare technology, robotics, automation, or other complex electromechanical products.
• Strong hands-on experience in multidisciplinary electromechanical product development.
• Experience taking products from concept through prototyping, testing, verification/validation, and manufacturing transfer.
• Proficiency with 3D CAD software, preferably SolidWorks or a similar platform.
• Strong understanding of mechanical systems, electronics, sensors, actuators, motors, and system integration.
• Experience with engineering analysis, troubleshooting, prototyping, and laboratory testing.
• Strong technical documentation and problem-solving skills.
• Ability to independently lead technical projects and make sound engineering decisions.
• Excellent communication skills and ability to collaborate effectively with cross-functional teams.

Preferred Qualifications

• Previous experience developing medical devices products.
• Knowledge of medical device design controls and risk management.
• Familiarity with ISO 13485, ISO 14971, IEC 60601, FDA requirements, or other applicable regulatory standards.
• Experience with electrical/electronic system integration, embedded systems, sensors, motors, motion control, or instrumentation.
• Experience with PCB design, microcontrollers, firmware, or control systems is an asset.
• Experience with Design for Manufacturing / Design for Assembly and product transfer.
• Experience working with contract manufacturers and external suppliers.
• Experience providing technical leadership or mentoring other engineers is strongly preferred.

Salary Range

CAD$80,000 – $90,000 annually.

Why Join Sonele

At Sonele, you’ll be part of a multidisciplinary team driving complex medical devices from idea to production. You’ll lead programs that combine precision engineering with real-world healthcare impact—supported by an organization committed to innovation, quality, and long-term customer partnerships. This is an opportunity to shape technical outcomes, interface directly with innovators, and help grow Canada’s hub for advanced medical device development. The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Please note that artificial intelligence (AI) technologies may be used during this recruitment process to assist with the evaluation of applications. These tools support, rather than replace, human judgment.