Senior Design Quality Assurance Engineer

2 weeks ago

Marlborough, Massachusetts, United States Boston Scientific Full time
About the Role

We are seeking a highly skilled Senior Design Quality Engineer to join our Core Stone franchise team. This is an exciting opportunity to support the development of high-visibility products and contribute to the growth of our organization.

Key Responsibilities
  • Support the execution and documentation of Design Validation & Verification and Usability activities
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
  • Provide quality and compliance input to project teams for project decisions and deliverables
  • Lead and support cross-functional root-cause analysis investigation and resolution activities
  • Check and provide support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Review and approve operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
  • Support regulatory submissions to notified bodies
Requirements
  • Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related field
  • 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
  • Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11
  • High energy problem solver capable of driving items to closure
  • Adaptable and effective collaborator in a team environment and in self-directed work
  • Strong communication skills (verbal & written)
Preferred Qualifications
  • Demonstrated use of Quality tools/methodologies
  • Experience in Electrical Medical Equipment (IEC 60601)

Boston Scientific is committed to advancing science for life and improving patient health. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and is essential to our mission. We stand for inclusion, equality, and opportunity for all.

We are an equal opportunity employer and welcome applications from diverse candidates. We maintain a prohibited substance free workplace and comply with all applicable state and federal law and healthcare credentialing requirements.

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