Design Quality II/Qualité de conception II

Boston Scientific•Montreal, QC

5d•CA$59,900 - CA$108,900•Hybrid

About The Position

We have an exciting opportunity for a Design Quality II supporting capital equipment within the BSC Electrophysiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and sustaining engineering experience. In a hybrid work mode, the Design Quality Engineer II will support a team of engineers to apply the directives of design controls to projects such as design changes, regulatory and standards compliance, corrective and preventive actions, and sustaining projects. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Montreal, QC, Canada location and requires being on-site at least three (3) days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Requirements

Bachelor’s degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline.
2+ years experience in design assurance, quality, or related medical device or regulated industry experience.
Knowledge of basic Quality System Requirements and Good Documentation Practices
High energy problem solver capable of driving items to closure
Adaptable and effective collaborator in a team environment and in self-directed work
Strong communication skills (verbal & written)
Proficiency in English is essential for effective communication and alignment.
Knowledge of English in addition to French (oral and written) is required.

Nice To Haves

Proven experience in a regulated medical device environment, preferably in a quality function
Experience working with cross-functional teams and driving projects to completion.
Prior interactions with the following disciplines: design controls, CAPA, risk management
Experience with Capital Equipment

Responsibilities

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Develops and executes plans for design control and risk management of complex projects
Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
Responsible for the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Participate in team decision-making and demonstrate strong communication and collaborative problem-solving skills.