Senior Design Assurance Engineer for Electrophysiology Devices
2 weeks ago
We are seeking a Senior Design Assurance Engineer to join our team in Mississauga, ON, CA. This position plays a critical role in ensuring the quality and safety of our electrophysiology devices.
About the Opportunity
This is an exciting opportunity to work with a talented team of professionals who are passionate about delivering high-quality medical solutions. As a Senior Design Assurance Engineer, you will be responsible for designing and implementing effective design controls, risk management strategies, and testing protocols to ensure the safe and effective operation of our electrophysiology devices.
Key Responsibilities
- Develop and implement design control and risk management plans for novel electrophysiology devices.
- Collaborate with cross-functional teams to identify and mitigate potential risks associated with device development.
- Design and execute testing protocols to validate device performance and ensure compliance with regulatory requirements.
- Contribute to the development of product risk management tools, such as Hazard Analysis, Fault Tree, and FMEAs.
- Maintain a strong understanding of industry regulations and standards related to medical device development.
Requirements
- Bachelor's Degree in Engineering (Mechanical or Biomedical preferred).
- At least 5 years of relevant work experience in design assurance or a related field.
- Experience with design controls, risk management, and testing protocols.
- Strong knowledge of industry regulations and standards related to medical device development.
Estimated Salary: $120,000 - $150,000 per year
Boston Scientific offers a competitive salary and benefits package, including health insurance, retirement savings plan, and paid time off.
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