Principal Design Quality Assurance Engineer

4 weeks ago


GondrecourtleChâteau, Grand Est, United States Boston Scientific Full time
About this role:

The Principal Design Quality Assurance Engineer is a seasoned professional with extensive experience and expertise in sustaining quality engineering and new product development. This role is responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet Boston Scientific, customer, and regulatory requirements.

This is a hybrid position that requires a minimum of three days per week in the office, with the flexibility to be located in Arden Hills, MN or Heredia, Costa Rica.

Key responsibilities:
  • Promote cross-functional collaboration and influence project strategy.
  • Lead the execution of quality deliverables, including project design and development plans, design changes, and design and usability validation plans.
  • Provide quality and compliance input and coaching for product development and/or post-market product sustaining activities.
  • Exercise considerable latitude in determining technical objectives and selecting methods and techniques to lead projects to completion.
  • Provide project direction, coaching, and mentoring for engineering and technical team personnel.
  • Develop solutions to complex and diverse technical problems.
  • Proactively investigate, identify, and implement best-in-class quality engineering practices.
  • Support internal and external regulatory audits.
  • Provide technical leadership to business units and advise management on potential improvements or enhancements to quality systems and processes.
Requirements:
  • BS in Electrical Engineering, Mechanical Engineering, or related degree.
  • Minimum of 7 years of medical device engineering experience or similarly regulated industry.
  • In-depth familiarity with FDA, ISO, MDD, EU MDR, and medical device industry quality requirements.
  • Solid technical writing skills.
  • Travel < 10% if required.
Preferred qualifications:
  • MS preferred.
  • Strong communication and presentation skills.


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