Senior Manufacturing Program Lead (MedTech & Hardware)

Inertia; Toronto; Hybrid; CAD 140,000 - 190,000; Full time

Job summary

Inertia is seeking an experienced Manager of Product Manufacturing to lead high-value, regulated hardware programs. You will oversee manufacturing readiness, design transfer, pilot builds, and production across ISO 13485 and ISO 9001 facilities in Toronto, with involvement in Guangzhou.

You will own the quality plan for each program and drive manufacturability and cost from concept through launch. You will lead engineers, technicians, and logistics staff, partnering with clients and suppliers to

Qualifications

• 10+ years of progressive experience in production of complex electromechanical products.
• 4+ years leading manufacturing programs from early customer engagement through design transfer, production, and sustainment.
• Experience in ISO 13485, FDA-regulated, or equivalent quality environment.
• Hands-on experience with design transfer, process validation (IQ, OQ, PQ), and CAPA.

Responsibilities

• Lead manufacturing programs from engineering release through design transfer, pilot build, validation, and production.
• Build and own the quality plan for each program, including DMR/DHR, pFMEAs, control plans, and work instructions.
• Plan and execute IQ/OQ/PQ and PPAP with engineering and quality teams.
• Drive DFM/DFA reviews, make-vs-buy decisions, and cost modeling during engineering.
• Manage scope, budget, schedule, quality, and risk for complex programs and communicate with clients.
• Qualify, manage, and audit suppliers and contract manufacturers in Canada and offshore.
• Coordinate production planning across Toronto and Guangzhou, including travel.
• Manage change control, nonconformance, and CAPA; support audits.
• Own quality tier assignment at proposal stage and contribute to scope/cost estimates.

Skills

Manufacturing leadership

Project management

Regulatory/compliance knowledge

Cross-functional collaboration

Vendor and supplier management

Manufacturing process knowledge

Education

Bachelor’s degree in Mechanical/Mechatronics/Industrial/Electrical Engineering

Tools

CAD tools

PDM/PLM systems

Jira

Job description

Inertia is seeking an experienced Manager of Product Manufacturing to lead high-value, regulated hardware programs. You will oversee manufacturing readiness, design transfer, pilot builds, and production across ISO 13485 and ISO 9001 facilities in Toronto, with involvement in Guangzhou.

You will own the quality plan for each program and drive manufacturability and cost from concept through launch. You will lead engineers, technicians, and logistics staff, partnering with clients and suppliers to