Design Assurance Manager

hace 4 días


San Francisco, Heredia, Costa Rica Boston Scientific A tiempo completo
About the Role

Boston Scientific is seeking a highly skilled Design Assurance Manager to lead a team in our Heredia CR location. This is an exciting opportunity to lead a team in sustaining single-use devices for our Peripheral Interventions business.

Key Responsibilities
  • Lead quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope.
  • Develop and implement quality strategies; seek 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.
  • Maintain and enhance cross-functional team relationships.
  • Provide significant guidance regarding technical strategies and approaches; work cross-functionally in identifying and resolving technical issues.
Requirements
  • Minimum of a Bachelor's degree.
  • Minimum of 10 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.
About Boston Scientific

Boston Scientific is a global leader in medical science, committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.



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