Design Assurance Quality Engineer III
1 week ago
The Design Assurance Quality Engineer III is a critical member of our medical device development team, providing quality engineering support to new product development projects and sustaining projects for current products on the market.
This hybrid position is based out of Montreal, Canada with an expectation to be in the office a minimum of three days per week.
Key Responsibilities- Provide quality and compliance input to project teams for project decisions and deliverables, ensuring adherence to BSC, customer, and regulatory requirements.
- SUPPORT SOFTWARE VERIFICATION AND VALIDATION ACTIVITIES FOR NEW PRODUCTS.
- Perform 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 prioritize patient safety.
- Support 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, NCEPs, CAPAs, PIRs, Field Signals Evaluations, and Field Actions.
- Apply technical skills, including sound, systematic problem-solving methodologies, to identify, prioritize, communicate, and resolve quality issues.
- Collaborate within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Work independently on highly specialized projects with long-range objectives.
- Ensure quality is integrated into all aspects of work by maintaining compliance to all quality requirements.
- Support internal and external regulatory audits as required.
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related field.
- A minimum of six years of medical device engineering experience.
- In-depth familiarity with FDA, ISO, MDD, EU MDR, and medical device industry quality requirements associated with product development, design controls, and product risk management.
- Strong communication and presentation skills.
- Solid technical writing skills.
Boston Scientific offers a competitive salary range for this position, commensurate with experience. The estimated salary range is between $90,000 and $130,000 per year, depending on qualifications and location.
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