Design Assurance Engineer II

Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
The Design Assurance Engineer provides support with the Watchman products which will provide the right candidate with excellent growth potential. He/she/they will support the ongoing product performance of minimally invasive coronary products which will provide the right candidate with excellent commercial experience and perspective in the medical device industry. He/she/they will work with a cross-functional team to maintain the design control and risk analysis files, analyze product performance, recommend appropriate action, and incorporate design and process improvements for structural heart devices currently in commercialization.

Your responsibilities will include:

• Maintain Risk Management File including Risk Change Analysis, Risk Management Plan/Report, Hazard Analysis, DFMEA, Task Analysis, and connections to PRA/Supplier Controls.
• Working with and influencing cross functional team to identify and/or implement changes enhancing product performance, improving manufacturability, or reducing cost
• Lead NCEP/CAPA activities in a cross-functional teamwork environment.
• Partner with R&D to determine and maintain Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Coordinate the execution and documentation of Design Validation and Verification activities associated with design change.
• Generate Design Verification and Validation protocols and reports.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
• Perform regulatory standard assessments and support regulatory submissions to notified bodies.
• Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Mentor cross functional team specifically with respect to NCEP/CAPA, design control, and risk management deliverables.

Required Qualifications:

• Minimum of a Bachelor’s degree in Biomedical Engineering, Mechanical, Chemical Engineering or related field of study
• Minimum of 2 years of related experience
• Medical device experience required

Preferred Qualifications:

• Experience with active product monitoring/complaints
• Previous design assurance or R&D experience in medical device industry
• ISO 13485, ISO 14971, and Quality System Regulations knowledge
• Self-motivated with a passion for solving problems and a bias for action
• Hands-on approach to problem solving
• Strong communication skills (verbal & written)

Requisition ID: 563474

As a leader in medical science for more than 40 years, we are 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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!