Senior Design Quality Engineer (Electrical Medical Equipment)

Additional Locations: Costa Rica-Heredia

Location Details: This is a hybrid position with the expectation to be in the office 3 days a week.  This position can be based in Arden Hills, MN or Heridia, Costa Rica.

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 is a quality engineer that directly supports medical device product development through the product lifecycle from concept through commercialization. This position will work with high performance cross-functional teams in the development and verification of electrical medical equipment to ensure delivery of the highest quality product to the customer. This position will initially focus on software for thrombectomy products in the Peripheral Interventions division.

Your responsibilities will include:

• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Proactively investigate, identify, and implement best-in-class Design Quality Engineering practices
• Monitors regulatory submission & audit questions and responses, proactively communicates lessons learned to internal customers and assists teams with response writing for product and quality system-related questions.
• Assist with engineering evaluations/generation and updates of procedures.
• Manage/improve systems and procedures from the Design Quality area.  
• Represent the division on various global Center of Practice quality system improvement projects by proactively soliciting input from stakeholders, reviewing proposals to assess impact on EP, and advocating for EP needs amongst global counterparts. 
• Potential to own quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.

What we're looking for in you:

Minimum requirements

What we’re looking for in you:

• Bachelor’s degree in electrical engineering, computer engineering, software engineering, or related discipline
• 5+ years of experience in design assurance, new product development, or related medical device experience
• Experience with medical electrical systems / electrical medical equipment / capital equipment
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• Ability to effectively work and collaborate in a mixed onsite and remote environment

Preferred qualifications

• Problem solver, capable of facilitating the problem-solving process
• Experience with software development 
• Knowledge of Medical Electronic Equipment Standards (IEC 60601-1, 60601-2)
• Formal training on statistical and quality techniques
• Front/Back-room audit experience

Requisition ID: 557486

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!