Senior Design Assurance Engineer

Additional Location(s):  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: 
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.  
 
Your responsibilities include: 

• Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success. 
• Able to understand device performance and anatomy interaction and identify opportunities for device and procedure improvements.
• Leads/supports the execution and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Leads the strategy, execution, and documentation of Validation and Verification activities.
• Applies 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.
• Able to 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.
• Works independently to plan and schedule own activities necessary to meet project goals and timelines. 

 
What we're looking for in you:
Required Qualifications:

• 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

Preferred Qualifications:

• 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)
   

Requisition ID: 590917

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place