Design Quality Engineer III - Interventional Cardiology

Boston Scientific-posted 2 days ago
$76,000 - $144,400/Yr
Full-time • Mid Level
Hybrid • Osseo, MN
5,001-10,000 employees
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Boston Scientific is currently recruiting for a Design Quality Engineer III in our Maple Grove, MN location.  This is an exciting opportunity to participate in the quality assurance of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.      The Design Quality Engineer III will support the application of design controls to focusing on new product development and sustaining engineering projects. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.

  • Identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
  • Develop, update, and maintain Design History File and Design Input / Output documentation
  • Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
  • Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
  • Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Bachelor's degree in an engineering discipline 
  • Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
  • Experience writing specifications, test protocols, and technical reports
  • Demonstrated use of quality tools and methodologies include DFMEA, Hazard Analysis, Root Cause Analysis
  • Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics
  • Strong communication skills (verbal and written). Effectively present complicated technical information to small and large audiences, from peers to senior leadership.
  • Bachelor's degree in mechanical, electrical, or biomedical engineering
  • Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
  • Experience in design engineering or process development, including design optimization and process validation
  • Adaptable and effective collaborator in a team environment and in self-directed work
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