Head of Manufacturing

Company Overview 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

Lead the development and scaling of manufacturing operations for blood purification devices, transitioning from prototype to commercial-scale production. Establish manufacturing processes and oversee production planning, quality systems, and supplier relationships.

Requires a Bachelor's or Master's degree in Engineering and proven leadership experience in medical device or regulated healthcare manufacturing. Must have strong knowledge of GMP and ISO 13485 standards.

• Production PlanningSouhaitée
• Résolution de problèmesSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Manufacturing Leadership
• Production Planning
• Quality Systems
• Supplier Management
• Contract Manufacturing
• GMP
• ISO 13485
• Clean Room Operations
• Cross-functional Leadership
• Commercialization
• Medical Device Manufacturing
• Problem-solving

• Manufacturing
• Healthcare
• Engineering
• Management & Leadership

Formation minimale

Baccalauréat

Expérience minimale

10+ ans

Postuler avant le

23 févr. 2027

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Director

Mode de candidature

La candidature directe est offerte