Project Manager - Medical Devices

Company Description Qidni Labs Inc. is a medical device company focused on revolutionizing dialysis technology for patients with kidney failure. The technology promises to make life-sustaining treatment more accessible globally. Enhancing the patient experience and improving quality of care is the top priority.

Role Description This is a full-time, on-site role located in Kitchener, ON. The Project Manager will coordinate cross-functional projects related to the development, testing, regulatory approval, and commercialization of Qidni’s medical devices.

Key Responsibilities

• Developing and maintaining project plans, schedules, budgets, and deliverables;
• Daily standup meetings ensuring team is tracking to their schedule and tasks;
• Coordinating activities across engineering, scientific, quality, regulatory, clinical, and manufacturing teams;
• Monitoring project progress and risks; facilitating team meetings, and;
• Ensuring action items are completed on time.

The Project Manager will also support vendor and contractor coordination, project documentation, resource planning, grant-funded project reporting, and communication with internal and external stakeholders. The ideal candidate is highly organized, proactive, and comfortable managing multiple priorities in a fast-paced startup environment.

Experience managing medical device, healthcare, engineering, or product development projects is strongly preferred. Familiarity with design controls, risk management, ISO 13485, and regulated product development is an asset.

Qualifications

• Bachelor’s degree in Engineering, Science, Business, Project Management, or a related discipline
• Minimum 7 years of experience in project management of medical devices (or similar, e.g. aerospace, automotive)
• Extensive experience developing schedules and budgets and human resources for 12-18 month projects of 10-15 person team
• Experience managing multidisciplinary technical or product development projects
• Strong organizational, scheduling, budgeting, and documentation skills
• Ability to identify project risks, resolve issues, and keep teams accountable to deadlines
• Ability to manage multiple projects at once, e.g. development of two medical devices in parallel
• Strong written and verbal communication skills
• Comfortable working with engineers, scientists, quality and regulatory professionals, suppliers, and external partners
• Proficiency with project management and collaboration tools
• Experience in a medical device, biotechnology, healthcare, or other regulated industry is preferred
• Familiarity with ISO 13485, medical device design controls, or quality management systems is preferred
• PMP, CAPM, or another recognized project management certification is an asset