Medical Device Design Assurance Leader

hace 3 días


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

Company Overview

Boston Scientific Corporation is a leading medical device manufacturer that values innovation, diversity, and inclusivity. We strive to create a collaborative culture that fosters growth and improvement in people's lives.

About the Role

This position involves leading cross-functional teams through product life cycles, ensuring project success by working with R&D, project management, manufacturing, regulatory, clinical, and marketing departments.

Key Responsibilities

  • Work cross-functionally to ensure project success
  • Understand device performance and anatomy interaction, identifying opportunities for device and procedure improvements
  • Determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
  • Maintain product risk management documentation (Hazard Analysis, Fault Tree, FMEAs)
  • Develop and coordinate Design Validation and Verification activities
  • Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
  • Lead CAPA, NCEP, Complaints, Failure Mode Investigations, etc.
  • Expertise in validation and statistical techniques to comply with regulatory requirements

Estimated Salary

$115,000 - $145,000 per year

Required Qualifications

  • Bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical, or related field
  • Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development, or related medical device experience
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
  • English language proficiency: 80-89%

Preferred Qualifications

  • Self-motivated with a passion for solving problems
  • Ability to manage multiple priorities and work with ambiguity
  • Strong communication skills (verbal & written)
  • Proficiency in collaborating with interdisciplinary teams

Benefits

Boston Scientific offers a comprehensive benefits package, including career growth opportunities, community involvement, and a collaborative work environment.



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