Medical Device 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

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.