Senior Design Quality / Qualité de conception senior

Senior Design Quality Professional

Location: Montreal, QC, Canada

Hybrid role – required to be on site at least three (3) days per week.

Boston Scientific does not offer visa sponsorship for this position.

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, with a strong focus on robustness of system design and documentation.
• 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 management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, so...