Senior Design Assurance Engineer

Boston Scientific - Maple Grove, MN

Full-time - Senior

Maple Grove, MN

Miscellaneous Manufacturing

About the position

We have an exciting opportunity for a Senior Design Assurance Engineer supporting front end WATCHMAN projects within the Interventional Cardiology division. This position supports a major product category with a focus on early feasibility project work with high visibility which will provide the right candidate with excellent growth potential. The Senior DA Engineer will work as a core team member with a high-performance cross-functional team to ensure safety, quality and compliance of WATCHMAN products to deliver the highest quality product to the customer. In this role, you will work cross-functionally with R&D, project management, manufacturing, regulatory, clinical, and marketing teams to ensure project success. You will be responsible for understanding device performance and anatomy interaction, identifying opportunities for device and procedure improvements, and leading the execution and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. You will maintain product risk management documentation, including Hazard Analysis, Fault Tree, and FMEAs, and lead the strategy, execution, and documentation of Validation and Verification activities. Additionally, you will apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. You will demonstrate a good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. The role requires you to navigate gray spaces by applying risk-based criteria to prioritize project work and mentor cross-functional teams through the product life cycle process, specifically regarding design control and risk management deliverables. You will work independently to plan and schedule your activities necessary to meet project goals and timelines.

Responsibilities

• Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical, and marketing to ensure project success.
• Understand device performance and anatomy interaction and identify opportunities for device and procedure improvements.
• Lead/support the execution and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Maintain product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Lead the strategy, execution, and documentation of Validation and Verification activities.
• 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 to comply with associated regulatory requirements and internal standards.
• Navigate gray space by applying risk-based criteria to prioritize project work.
• Mentor cross-functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
• Work independently to plan and schedule own activities necessary to meet project goals and timelines.

Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field of study
• 5 years experience in Design Assurance, new product development or related medical device experience
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

Nice-to-haves

• Early feasibility study development project experience
• Self-motivated with a passion for solving problems and a bias for action
• Ability to manage multiple priorities and work with ambiguity
• Hands-on approach to product development
• Strong communication skills (verbal & written)