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Boston Scientific Design Assurance Manager 
Costa Rica, Heredia 
606812901

13.12.2024

Hybrid Roles:


Key responsibilities include:

  • Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope. Key Quality voice of influence on projects.
  • Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
  • Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
  • Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
  • Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
  • Maintains and enhances cross-functional team relationships.
  • Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
  • Directly interfaces with internal and external audit activities.


What we're looking for in you:

Required Qualifications:

  • Minimum of a Bachelor's degree
  • Minimum of 7 years of related work experience or an equivalent combination of education and work experience
  • Proven technical leadership and project management skills in medical device design, development, and commercialization
  • Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
  • Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
  • Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
  • Medical Device or regulated industry experience


Preferred qualifications:

  • Bachelor in an engineering discipline
  • Advanced degree in technical field or business.
  • Experience leading technical teams.
  • Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
  • Familiarity with BSC products and customer needs