The calibration and maintenance SME is a member of the Boston Scientific Corp (BSC) Integration team. This individual will support the integration of the Access Solutions (Baylis) sites and product portfolio into the BSC framework for an estimated 18-month period. This individual will create equipment documentation and execute equipment calibrations and maintenance within the BSC quality system. The EE will work at the Cartago, Costa Rica site with potential travel to Mississauga, Canada. This individual will report work activities and progress to the Integration Equipment Lead.

Key Responsibilities

  • Collaborates cross functionally with the operations integration team (quality, process, equipment, site production, and manufacturing).
  • Prepares equipment documentation remediation, calibration and maintenance executions, and sets up new equipment development in conjunction with the local Access Solutions team and Production and Process Controls (P&PC) team to ensure requirements of the BSC quality system are met.
  • Performs equipment improvement projects within Boston Scientific’s governing standard operating procedures.
  • Collaborates with the P&PC team to develop implementation strategy and associated documentation. (MVPs, PRAs, MIs, Integration PCAs, etc.)
  • Identifies, implements, and manages equipment requirements driven by the Boston Scientific Quality System to support production and business goals.
  • Proactively investigates, identifies, and implements best in class metrology and maintenance practices in alignment align with standards and BSC global requirements.
  • Trains and supports Access Solutions staff on Boston Scientific systems and procedures.
  • Interacts with Access Solutions leadership to share their specialized skills to develop a knowledge base of the Boston Scientific Quality System and procedures for future development of the manufacturing sites and employees.
  • Helps mature and refine product and manufacturing to support future regulatory requirements required by the Boston Scientific Quality System.


Requisitos Adicionales:

Required Qualifications or Skills

  • Non-device software and equipment expertise.
  • Calibration/metrology and maintenance expertise.
  • Understanding of BSC calibration and maintenance systems and their tie-ins to and impact on other business processes.
  • Understanding of equipment prints, specifications, and requirements.
  • Good cross-functional communication skills with different project stakeholders.
  • Able to coordinate tasks with different functions to ensure execution of assigned deliverables.
  • Bachelor’s degree in Mechanical, Electromechanical, Electronic, Electrical Industrial Maintenance or related field.
  • English Level required: B2 (70% – 79%).
  • At least 2 years of experience in similar position.

Quality System Requirements

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a workplace that supports the Quality Policy and Quality System.