Design Assurance Engineer for Cutting-Edge Medical Devices
2 months ago
About Boston Scientific
At Boston Scientific, we are dedicated to transforming lives through innovative medical solutions. Our mission is to advance science for life by developing groundbreaking technologies that improve patient outcomes and enhance the quality of care.
The Role: Design Assurance Engineer III
We are seeking a highly motivated and experienced Design Assurance Engineer III to join our growing team. In this role, you will play a crucial part in ensuring the safety and efficacy of our next-generation capital equipment devices.
Your Responsibilities:
- Lead the design control and risk management processes for innovative medical devices.
- Leverage clinical knowledge and data to influence device design and testing strategies.
- Develop and implement robust product risk management tools, including Hazard Analysis, Fault Tree Analysis, and Failure Mode and Effects Analysis (FMEA).
- Champion a culture of quality by ensuring compliance with all relevant standards and regulations, such as ISO 13485, ISO 14971, IEC , and IEC 62304.
- Collaborate effectively with cross-functional teams to ensure seamless integration of design assurance principles throughout the product development lifecycle.
Your Qualifications:
- Bachelor's Degree in Engineering (Electrical or Biomedical preferred).
- 3+ years of experience in the medical device industry, with a focus on design assurance and risk management.
- Strong understanding of relevant quality standards and regulatory requirements.
- Excellent communication, interpersonal, and problem-solving skills.
Preferred Qualifications:
- Six Sigma problem-solving methodologies.
- Training experience in FDA regulations or ISO standards.
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