Engineering Project Lead

Sonele Inc.; Markham; On-site; CAD 110,000 - 135,000; Full time

Benefits offered by this job

None

Job summary

Sonele Inc. is seeking an Engineering Project Lead – Medical Device Development to oversee all engineering aspects of electro‑mechanical medical device projects.

You will interpret customer requirements, develop proposals, lead design and prototyping, and ensure a smooth transition to manufacturing. The role requires strong mechanical design, project management, and client-facing communication skills, with ISO 13485 experience and proven leadership across multidisciplinary teams.

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Mechatronics, or Biomedical Engineering or related discipline.
• 7+ years of product design and development experience in 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 assembly, testing, and troubleshooting.
• Knowledge of electrical subsystems and system integration.
• Experience working under ISO 13485 or other regulated quality systems (FDA, aerospace, defense).
• Excellent communication and technical documentation skills; experience interacting with customers and cross‑functional teams.

Responsibilities

• 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 with management and cross‑functional teams.
• Lead design reviews, requirements traceability, and verification planning per ISO 13485 design control.
• Provide clear and proactive communication with clients and internal stakeholders on progress, changes, and risks.
• Lead mechanical design and development of electro‑mechanical assemblies, enclosures, mechanisms, and fixtures.
• Generate CAD models, drawings, and tolerance analyses using SolidWorks.
• Support design transfer activities including pilot builds, IQ/OQ/PQ, and documentation handoff.
• Ensure project documentation (DHF, DMR, risk files) is complete and audit ready.

Job description

Role Summary

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.