Senior Design Assurance Engineer
7 days ago
About the Role
We are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team at Boston Scientific. This position plays a critical role in ensuring the quality and safety of our medical devices, working closely with new product development and product life cycle teams.
Key Responsibilities
- Develop and implement design control and risk management strategies for novel electrophysiology devices.
- Collaborate with cross-functional teams to identify and mitigate quality risks.
- Apply sound problem-solving methodologies to resolve quality issues and improve product design.
- Lead the development and implementation of product risk management tools, such as Hazard Analysis and Fault Tree Analysis.
- Ensure compliance with regulatory requirements and internal standards, including ISO 13485 and ISO 14971.
- Contribute to a culture of quality-centric patient care and customer satisfaction within the New Product Development team.
- Provide quality input and expertise to project teams, ensuring that products meet the highest standards of quality and safety.
Requirements
- Bachelor's Degree in Engineering (Mechanical or Biomedical preferred).
- 5+ years of experience in the medical device industry, with a focus on design controls and risk management.
- Knowledge of ISO 13485, ISO 14971, and IEC standards.
- Excellent analytical and communication skills, with the ability to work effectively in a team environment.
- Strong organizational and time management skills, with the ability to prioritize multiple tasks and meet deadlines.
Preferred Qualifications
- 2+ years of experience in a Design Assurance role, with a focus on electrophysiology devices.
About Boston Scientific
Boston Scientific is a global leader in medical science, committed to solving the challenges that matter most in healthcare. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for our customers and employees.
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