Manufacturing Director - Medical Devices & Scale-Up

Qidni Labs; Kitchener; Vor Ort; CAD 120.000 - 180.000; Vollzeit

Zusammenfassung

Qidni Labs in Kitchener, ON is seeking a Head of Manufacturing to lead the development and scaling of its production operations for blood purification devices.

You will establish processes, manage production planning and quality systems, coordinate contract manufacturing, and work across engineering, regulatory and quality teams to meet regulatory and business goals.

The role requires a hands-on, fast-paced startup mindset with experience in medical devices and GMP/ISO13485 compliance.

Qualifikationen

• Bachelor’s or Master’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering.
• Proven manufacturing leadership in medical devices or regulated industries.
• Experience scaling from prototype to commercialization.
• Strong GMP, ISO 13485 knowledge.
• Experience with suppliers and contract manufacturers.
• Cross-functional collaboration with engineering, regulatory and quality teams.
• Experience with clean room operations is a plus.

Aufgaben

• Establish manufacturing processes for scalable production.
• Oversee production planning, scheduling and quality systems.
• Coordinate supplier and contract manufacturing relationships.
• Support transition from prototype to commercial-scale production.
• Collaborate with engineering, regulatory and quality teams to meet requirements.

Kenntnisse

Manufacturing leadership

GMP/ISO 13485 knowledge

Procurement & contract manufacturing

Cross-functional collaboration

Process development & scaling

Ausbildung

Bachelor’s or Master’s in Mechanical Engineering

Manufacturing Engineering

Industrial Engineering

Biomedical Engineering

Jobbeschreibung

Qidni Labs in Kitchener, ON is seeking a Head of Manufacturing to lead the development and scaling of its production operations for blood purification devices.

You will establish processes, manage production planning and quality systems, coordinate contract manufacturing, and work across engineering, regulatory and quality teams to meet regulatory and business goals.

The role requires a hands-on, fast-paced startup mindset with experience in medical devices and GMP/ISO13485 compliance.