Design Assurance Engineer III

1 week ago


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

We are seeking a highly skilled Design Assurance Engineer III to join our team at Boston Scientific. As a key member of our EP division, you will play a critical role in ensuring the safety, quality, and compliance of our cardiac mapping and ablation systems.

Responsibilities
  • Work collaboratively with cross-functional teams to ensure project success, including R&D, project management, manufacturing, regulatory, clinical, and marketing.
  • Lead and support the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Maintain product risk management documentation, including Hazard Analysis and FMEAs.
  • Lead and support the development of and coordinate the execution and documentation of Design Validation and Verification activities.
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Support and lead the execution and investigation of CAPAs, NCEPs, Complaints, Failure Mode Investigations, etc.
Requirements
  • Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical, or related field of study.
  • Minimum 5 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing, or related medical device experience.
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
  • Experience navigating design, manufacturing, and/or supplier variations.
Preferred Qualifications
  • Strong understanding of NCEP/CAPA processes.
  • Previous experience working to create/maintain risk documentation such as FMEAs and HAs.
  • Experience working with Stature or FMEA MED-8 software.
  • Self-motivated with a passion for solving problems and a bias for action.
  • Ability to manage multiple priorities and work with ambiguity.
  • Strong communication skills (verbal and written).
  • Proficiency in collaborating with interdisciplinary teams.
What We Offer

Boston Scientific is committed to advancing science for life and improving patient health. We offer a dynamic and inclusive work environment, opportunities for professional growth and development, and a competitive compensation package.

We are an equal opportunity employer and welcome applications from diverse candidates. Please note that certain US-based positions require acceptable proof of COVID-19 vaccination status.



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