Design Quality Assurance Engineer III - WATCHMAN

bostonscientific • Maple Grove, MN

1d • $76,000 - $144,400 • Hybrid

About The Position

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 Design Quality Assurance Engineer III 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 Design Quality Assurance Engineer III supports a major product category with high visibility which will provide the right candidate with excellent growth potential and perspective in the medical device industry. In this position you will work with a cross-functional team to support medical device product development from development through commercialization and ensure the safety, quality and compliance of launched products by establishing and maintaining the design control deliverables and risk management activities. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Weaver Lake Campus in Maple Grove, MN and requires being on-site at least three days per week. Relocation assistance: Relocation assistance may be available for this position at this time. Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

• Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent
• Minimum of 3 years of experience in design assurance, quality, product development or related medical device or regulated industry experience
• Some experience in sustaining or new product development: e.g. creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), design verification
• ISO 13485, ISO 14971, and Quality System Regulations understanding
• Strong communication skills (verbal & written) and presentation skills

Nice To Haves

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

Responsibilities

• In-depth understanding and application of Design Control and Risk Management concepts.
• Provide quality and compliance input to project teams.
• Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
• Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
• Support regulatory submissions to notified bodies.
• 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, with guidance/collaboration of the team

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees