Senior Quality Design Assurance Engineer

Additional Locations:
Canada-QC-MontrealDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing - whatever your ambitions.About the roleThe ideal Senior Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative cardiovascular products.
Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.Your responsibilities will include:
Developing an understanding of Design Controls, Risk Management and Usability for Medical Devices.Providing 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).Providing quality and compliance input for post market product sustaining activities, such as design changes, NCEP's, CAPA's, PIRs, Field Signals Evaluations and Field Actions.Applying technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.Building quality into all aspects of work by maintaining compliance to all quality requirements.Supporting internal and external regulatory audits as required.Other duties as necessary or required by the organization.Required qualifications:
Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent.7+ years of work experience relating to quality assurance in a highly regulated industry.Medical device experience.Competent with use of Microsoft Office Suite.Preferred QualificationsFocus on detailed work with emphasis on accuracy and completeness.Excellent organizational and planning skills; drives for results.Strong communication (oral and written) and presentation skills.High energy problem solver capable of driving items to closure.Ability to collaborate and work on a global team.Requisition ID:
594178As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to uphold those values in everything we do - as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE:
BSX) isn't just business, it's personal.
And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
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