Location
Montreal, Quebec, Canada. Hybrid: required to work onsite at least three days per week.
About the role
Senior Design Quality professional to lead design assurance efforts for a critical medical device in the Electrophysiology space. This self‑driven role requires independently managing complex technical challenges across hardware, software, and system domains.
Key Responsibilities
- Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
- Independently lead design control activities for the Capital Equipment, including design & development planning, risk management, design verification, and validation efforts.
- Collaborate closely with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design and compliance matters throughout the product lifecycle.
- Own and maintain comprehensive risk m...