Design Quality Assurance Engineer III - WATCHMAN

Boston Scientific • Maple Grove, MN

3d

About The Position

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

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
• ISO 13485, ISO 14971, and Quality System Regulations understanding
• Strong communication skills (verbal & written) and presentation skills
• 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

Nice To Haves

• 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

Responsibilities

• Provide quality and compliance input to project teams.
• Develop, update, and maintain Design History File
• 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