At a Glance
- Tasks: Lead design assurance for innovative electrophysiology medical devices and tackle technical challenges.
- Company: Join Boston Scientific, a leader in medical technology with a focus on quality and safety.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on mentorship and career advancement.
- Why this job: Make a real impact on healthcare by ensuring the safety and effectiveness of cutting-edge devices.
- Qualifications: Bachelor’s degree in engineering and over six years in medical device quality or design assurance.
The predicted salary is between 98550 - 120450 $ per year.
Lead design assurance for electrophysiology medical devices using risk management and system quality expertise in hybrid Montreal work. Influence safety, compliance, and robust design across complex products. Boston Scientific seeks a Senior Design Quality Engineer to manage technical challenges across hardware, software, and system domains. You will lead design controls, support product lifecycle decisions, and influence strategic quality initiatives. The position requires expertise in medical device quality systems, risk documentation, and software validation.
Key Responsibilities:
- Lead design planning, risk management, verification, and validation activities
- Serve as Quality’s technical authority for system integration decisions
- Maintain hardware, software, and system risk management files
- Investigate test failures, CAPAs, NCEPs, and complaints
- Guide audits, inspections, and junior engineer development
Requirements:
- Bachelor’s degree in engineering or related technical discipline
- Six-plus years in medical device quality or design assurance
- Expertise in ISO 14971, 21 CFR 820, and ISO 13485
- Experience leading complex software and system quality activities
- Strong communication, investigation, and stakeholder influence skills
Apply design controls, risk management, and system quality expertise to advance electrophysiology device assurance at Boston Scientific.
Senior Design Assurance Engineer Electrophysiology in Montréal employer: Boston Scientific
Boston Scientific is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals passionate about advancing medical technology. With a strong emphasis on employee growth and development, team members are encouraged to enhance their skills through various training programs and leadership opportunities. Located in a vibrant area, employees benefit from a dynamic environment that supports both personal and professional fulfillment while contributing to meaningful healthcare solutions.
