Principal Design Quality Engineer

Work mode: Hybrid

Onsite Location(s): Maple Grove, MN, US, 55311

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 Principal Design Quality Engineer supporting WATCHMAN projects within the BSC's Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. In a hybrid work mode, the Principal Design Quality Engineer supports a major product category with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The engineer will provide quality engineering support to operations, product development, and sustaining projects for current products on the market. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Principal Design Quality Engineer will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional, and corporate quality goals and priorities and will provide quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

Your responsibilities include:

• Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and work with R&D for Design Input/Output documentation (Product Specification, Component Specifications, and Prints)
• Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
• Support regulatory submissions to notified bodies.
• Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
• Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, while also mentoring others to enhance their skills and expertise.

What We're Looking For In You

Required Qualifications:

• Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent.
• Minimum of 5 years of experience in design assurance, quality, or related medical device or regulated industry experience with an ability to develop clinical understanding
• Demonstrated independent ownership and completion of project deliverables for multiple design projects.
• Self-motivated with a passion for solving problems and a bias for action.
• ISO 13485, ISO 14971, and Quality System Regulations understanding
• Excellent communication skills (verbal & written) and presentation skills

Preferred Qualifications:

• Focus on detailed work with emphasis on accuracy and completeness
• High energy problem solver capable of driving items to closure
• Excellent organizational and planning skills; drives for results
• Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.