Engineering Project Lead

Gexel Telecom International Inc.; Markham; On-site; CAD 110,000 - 135,000; Full time

Benefits offered by this job

Experience in CDMO/OEM environments

Regulatory standards: IEC 60601, ISO L

Process validation knowledge

PMP or PM training

SolidWorks, PLM/ERP, MS Project

Job summary

Sonele is seeking an Engineering Project Lead to act as the primary technical lead for electro‑mechanical medical device development projects in Canada. You will guide design, prototyping, and verification, ensuring successful manufacturing transfer while maintaining regulatory alignment.

The role requires strong mechanical design and PM skills, experience with ISO 13485, and close collaboration with customers and internal teams across disciplines.

Qualifications

• 7+ years of experience in product design and development within medical devices or precision electro‑mechanical systems.
• Strong mechanical design and prototyping skills with experience in assembly, testing, and troubleshooting.
• Experience leading projects through all phases of the product lifecycle.
• Knowledge of electrical subsystems and system integration.
• Familiarity with ISO 13485 or other regulated quality systems.
• Excellent communication and documentation skills with customers and cross‑functional teams.

Responsibilities

• Lead project efforts as primary technical contact and owner for programs.
• Review requirements, define scope and schedules with stakeholders.
• Develop proposals, estimates, and plans with management.
• Oversee design reviews, risk analyses, and verification planning per ISO 13485.
• Coordinate design transfer and manufacturing readiness activities.
• Collaborate with manufacturing and quality teams to ensure audit-ready documentation.

Skills

Mechanical design

Prototyping

Project management

Customer communication

Education

Bachelor’s or Master’s degree in Mechanical, Mechatronics, or Biomedical Engineering (or related discipline)

Tools

SolidWorks

PLM/ERP systems

Microsoft Project

Job description

Engineering Project Lead

The Engineering Project Lead – Medical Device Development serves as the primary technical lead and project owner for customer-driven product development programs. In this role, you will oversee all engineering aspects of electro‑mechanical medical device projects: interpreting customer requirements, developing proposals, leading design and prototyping, coordinating multidisciplinary teams, and ensuring successful transition to manufacturing. You will combine strong mechanical design experience with project management and client‑facing communication skills—bridging technical execution and customer alignment.

Key Responsibilities

Project Leadership & Customer Engagement

• Act as the primary technical contact for assigned customer programs after handoff from business development.
• Review customer requirements, specifications, and risk analyses; define technical scope, deliverables, and schedules.
• Develop proposals, estimates, and project plans in coordination with management and cross‑functional teams.
• Lead design reviews, requirements traceability, and verification planning in compliance with ISO 13485 design control procedures.
• Provide clear and proactive communication with clients and internal stakeholders on technical progress, changes, and risks.

Engineering Design & Prototyping

• Lead and contribute hands‑on to mechanical design and development of electro‑mechanical assemblies, enclosures, mechanisms, and fixtures.
• Generate CAD models, detailed drawings, and tolerance analyses using SolidWorks or equivalent tools.
• Integrate mechanical designs with electrical and embedded components; support system‑level layout and packaging.
• Direct and participate in prototyping, mechanical testing, and design verification activities.
• Perform design iterations based on testing outcomes and customer feedback to achieve performance, cost, and manufacturability objectives.

Design Transfer & Manufacturing Readiness

• Collaborate with manufacturing, process, and quality teams to establish production methods, travelers, and inspection criteria.
• Lead design transfer activities including pilot builds, process validation (IQ/OQ/PQ), and documentation handoff.
• Support supplier qualification, material selection, and manufacturability improvements.
• Ensure all project documentation (DHF, DMR, risk files, change records) is complete, accurate, and audit ready.

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Mechatronics, or Biomedical Engineering (or related discipline).
• 7+ years of experience in product design and development within medical devices or precision electro‑mechanical systems.
• Proven ability to manage technical projects through all phases of the product lifecycle.
• Strong mechanical design and prototyping skills with experience in assembly, testing, and troubleshooting.
• Knowledge of electrical subsystems and system integration.
• Demonstrated experience working under ISO 13485 or other regulated quality systems (FDA, aerospace, defense).
• Excellent communication and technical documentation skills; experience interacting directly with customers and cross‑functional teams.

Assets

• Experience within a medical device contract development/manufacturing (CDMO/OEM) environment.
• Knowledge of IEC 60601, ISO 14971, and design‑for‑manufacture (DFM/DFX) best practices.
• Familiarity with process validation (IQ/OQ/PQ), vendor management, and supply chain coordination.
• PMP certification or formal project management training.
• Proficiency in SolidWorks, PLM/ERP systems, and Microsoft Project (or equivalent tools).

Salary Range

CAD$110,000 – $135,000 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.