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Medical Device Quality Assurance Engineer
1 month ago
About the Role:
The Design Assurance Quality Engineer III provides quality engineering support to new product development projects and sustaining projects for current products on the market. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
This role is a hybrid position based out of Montreal, Canada with the expectation to be in the office a minimum of three days per week.
Your Responsibilities Will Include:
- Provide 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).
- Supports software verification and validation activities for new product.
- Performs risk evaluation and associated management activities related to product development including product risk analysis and mitigation of software issues to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
- Supports product cybersecurity assessments in conjunction with a cross-functional team.
- Provide 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.
- Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Capable of working independently on highly specialized projects with long range objectives.
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
- Support internal and external regulatory audits as required.
Required Qualifications:
- BS in Electrical Engineering, Mechanical Engineering or related degree.
- Minimum of 6 years of medical device engineering experience.
- In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
- Strong communication and presentation skills.
- Solid technical writing skills.
Preferred Qualifications:
- Focus 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
At Boston Scientific, 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.
