Senior Calibration Engineer

Senior Calibration Engineer

Responsible for metrology strategy and the end-to-end management of calibration and measurement systems used to ensure product, process, and equipment compliance in a regulated medical device environment. Plan and oversee the site's metrology and laboratory activities, including calibration requirements, equipment calibration specifications and procedures, measurement uncertainty analysis, traceability, and continuous improvement of the metrological confirmation system. Partner cross-functionally to ensure measurement systems are fit for intended use, appropriately validated, and compliant with ISO 17025, ISO 13485, FDA expectations, and Quality System requirements.

Your responsibilities include:
Interface with Manufacturing, Quality, R&D, Validation, and Supplier Quality teams to define metrology requirements, critical measurement parameters, and calibration strategies for new and existing equipment, tools, and processes. Manage the full calibration lifecycle for IM&T equipment, including determination of calibration need, asset setup, calibration intervals, scheduling, labeling, certificate review, recall, and removal from service. Develop, review, and approve Equipment Calibration Specifications (ECS), Equipment Calibration Procedures (ECP), calibration procedures, measurement templates, and supporting metrology rationale documentation.

Ensure measurement traceability to national or international standards, maintain appropriate reference standards and standard reference materials, and apply sound metrology practices for test accuracy ratios and calibration adequacy. Lead Measurement System Analysis (MSA), including gage R&R and related statistical studies, to assess repeatability, reproducibility, and fitness for intended use of measurement systems and laboratory methods. Oversee metrology readiness and qualification support for equipment, fixtures, and systems used in manufacturing, validation, and laboratory environments, ensuring measurement controls remain appropriate for intended use and regulatory expectations.

Coordinate all activities related to the Metrologic Confirmation System for measuring instruments at the Boston Scientific Costa Rica site. Manage and improve the Metro logical Confirmation System, including calibration planning, calibration programming, service-provider oversight, and compliance with ISO/IEC 17025 expectations. Improve the technical competitiveness of the laboratory through personnel development, infrastructure improvement, operational effectiveness, and compliance with applicable national and international regulations.

Review and approve calibration documentation, calibration forms, and related metrology records to ensure technical adequacy and quality-system alignment. Perform calibrations, develop new calibration procedures, and provide metrological support to production, quality, transfers, validations, and other areas of the company. Support the creation of the Quality Department budget based on Metrology Laboratory needs and contribute to broader site support activities as required.

Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and documented quality processes and procedures. Assure that appropriate resources, including personnel and tools, are maintained to support Quality System compliance and adherence to the BSC Quality Policy. Provide day-to-day supervision and tactical oversight to a production or support team by setting expectations, coaching performance, coordinating activities, and monitoring quality and work progress.

Promote continuous improvement by reviewing processes, implementing performance evaluation tools, and creating systems to receive and implement improvement ideas. Make decisions that directly impact the quality, efficiency, and effectiveness of tasks performed or services provided by the team. Communicate standard information with tact and diplomacy, exchange ideas clearly and logically, and involve the appropriate stakeholders when needed. Ensure awareness of, and promote a work environment that supports, implementation of EHS…