Senior Design Assurance Lead

hace 2 semanas


San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo
Job Description

We are seeking a Senior Design Assurance Lead to join our team at Boston Scientific Corporation.

About the Role:

The successful candidate will have extensive experience in Quality Assurance and/or Design Assurance, New Product Development, or related medical device experience. They will lead cross-functional teams through product life cycles, ensuring project success by understanding device performance and anatomy interaction, identifying opportunities for improvement, and implementing design controls based on risk management and customer needs.

Key Responsibilities Include:

  • Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical, and marketing to ensure project success.
  • Lead the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Maintain product risk management documentation (i.e., Hazard Analysis, Fault Tree, FMEAs).
  • Lead the development of and coordinates the execution and documentation of Design Validation and Verification activities.
Required Qualifications:
  • Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical, or related field of study.
  • English Language Proficiency: 80-89%.
  • Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development, or related medical device experience.
Preferred Qualifications:
  • 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 & written).
  • Proficiency in collaborating with interdisciplinary teams.

Estimated Salary: $120,000 - $150,000 per year



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