About the Company: Boston Scientific is committed to solving important health industry challenges by working in diverse teams of high-performing employees. With access to the latest tools and training, employees are supported in advancing their skills and career.
About the Role: We are looking for a Senior Design Assurance Engineer to support front end WATCHMAN projects within the Interventional Cardiology division. This role involves working with a cross-functional team to ensure safety, quality, and compliance of WATCHMAN products.
Responsibilities:
- Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical, and marketing teams.
- Understand device performance and anatomy interaction for identifying opportunities for improvements.
- Lead/support the execution and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
- Maintain product risk management documentation.
- Lead the strategy, execution, and documentation of Validation and Verification activities.
- Apply problem-solving methodologies in identifying and resolving quality issues.
- Demonstrate knowledge of validation and statistical techniques to comply with regulatory requirements.
- Mentor cross-functional teams through the product life cycle process.
- Independently plan and schedule activities to meet project goals and timelines.
Qualifications:
- Required Skills:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
- 5 years of experience in Design Assurance or related medical device experience.
- Understanding of ISO 13485, ISO 14971, and Quality System Regulations.
- Preferred Skills:
- Experience in early feasibility study development projects.
- Self-motivated with a passion for problem-solving.
- Ability to manage multiple priorities and work with ambiguity.
- Hands-on approach to product development.
- Strong communication skills (verbal & written).
Pay range and compensation package: Not specified.
Equal Opportunity Statement: Boston Scientific is committed to diversity, equality, and opportunity for all employees. The company is an equal opportunity employer and maintains a prohibited substance free workplace.
