Medical Devices Quality Assurance Specialist
2 weeks ago
As a R&D Test Engineer II, you will play a pivotal role in ensuring the quality and reliability of our medical device products. Collaborating with cross-functional teams, you will design, develop, and execute comprehensive test plans to ensure compliance with industry standards and regulations.
Your Responsibilities:- Analyze system requirements to create test plans and protocols that meet design specifications.
- Conduct engineering and design performance tests to validate product functionality.
- Analyze test results, identify issues, and track root causes to inform product improvements.
- Develop engineering and design verification test reports to document product testing outcomes.
- Work collaboratively with a cross-functional team to achieve shared goals.
- Ensure compliance of project deliverables to regulatory standards and support system owners during external audits.
- Plan and schedule own activities to meet timelines, communicate progress timely, and work independently when necessary.
- Undergraduate or master's degree in engineering or a related field.
- 2+ years of relevant test engineering experience.
- Strong problem-solving skills in a team environment.
- An analytical approach to work, with confidence in influencing people at all levels.
- Excellent organizational, planning, communication, and collaboration skills.
- Strong documentation skills.
- Technical knowledge of testing concepts for electrical/electro-mechanical equipment.
- Knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Knowledge of ISO 14971.
- Knowledge of IEC 60601 series of standards.
This is a hybrid position based out of Montreal, Canada, with an expectation of being in the office a minimum of three days per week. With a salary range of $80,000 - $110,000 annually, depending on experience, this role offers a competitive compensation package.
Boston Scientific is a leader in medical science, 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.
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