Head of Manufacturing

Qidni Labs; Kitchener; On-site; CAD 120,000 - 180,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Manufacturing leadership

GMP/ISO 13485 knowledge

Procurement & contract manufacturing

Cross-functional collaboration

Process development & scaling

Education

Bachelor’s or Master’s in Mechanical Engineering

Manufacturing Engineering

Industrial Engineering

Biomedical Engineering

Job description

Qidni Labs Inc. is a medical device company focused on revolutionizing dialysis technology for patients with kidney failure. The technology promises to miniaturize the dialysis machine and reduce the amount of fluid required for treatment, making life-sustaining treatment more accessible globally. Enhancing the patient experience and improving quality of care is the top priority.

Role Overview

This is a full-time, on-site role located in Kitchener, ON. As the Head of Manufacturing, the candidate will lead the development and scaling of Qidni Labs’ manufacturing operations for its blood purification devices.

Responsibilities include establishing manufacturing processes, overseeing production planning and quality systems, coordinating supplier and contract manufacturing relationships, and supporting the transition from prototype to commercial-scale production. The role will require working cross-functionally with engineering, regulatory and quality teams to ensure manufacturing processes meet regulatory and operational requirements.

The ideal candidate will have experience building manufacturing operations within the medical device or regulated healthcare industry and be comfortable working in a fast-paced startup environment.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering or a related discipline
• Proven capabilities in manufacturing leadership, preferably within medical devices or regulated industries
• Experience developing and scaling manufacturing processes from prototype to commercialization
• Strong knowledge of GMP, ISO 13485, and medical device manufacturing standards
• Experience managing suppliers, contract manufacturers, and production workflows
• Excellent organizational, leadership, and problem-solving skills
• Ability to work cross-functionally with engineering, regulatory, and quality teams
• Experience with clean room operations is an asset