Senior Calibration Engineer

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.

About the Role

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. Scope includes laboratory operations, calibration lifecycle management, supplier calibration oversight, audit support, equipment qualification support, and metrology capability development for both new product development and sustaining operations.

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 Metrological 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 and Energy Policies relevant to the position.
• Review internal and external calibration results, including as-found and as-left data, identify out-of-tolerance conditions, perform impact assessments, and drive appropriate containment and corrective actions prior to return to service.
• Manage external calibration service providers, verify approved vendor and ISO 17025 requirements where applicable, communicate technical requirements, and monitor supplier performance and calibration certificate quality.
• Support internal, customer, and regulatory audits by preparing objective evidence, defending metrology and calibration practices, and closing actions related to traceability, TAR, OOT, records, labeling, and supplier calibration controls.
• Provide technical leadership for metrology laboratory operations and strategy, including capability expansion, process improvement, turnaround optimization, documentation quality, and metrology support to production, quality, transfers, and validations.
• Train technicians, engineers, and users in calibration methods, measurement uncertainty, traceability, MSA, instrument selection, interpretation of calibration data, proper care and use of measuring instruments.
• Ensure appropriate resources, including personnel, tools, standards, and systems, are maintained to support Quality System compliance and adherence to the Quality Policy.
• Establish and promote a work environment that supports the Quality Policy and Quality System.

What We’re Looking For:

• Licentiate or bachelor's degree in industrial, Electronic, Biotechnology, Electromechanical Engineering, Physics, Metrology, or related field.
• At least 5 years of experience in metrology, calibration systems, or laboratory management in a regulated manufacturing or medical device environment.
• Strong hands-on experience in calibration laboratories and measurement systems covering pressure, temperature, force, dimensional, and time-related equipment.
• Strong knowledge of metrological traceability, measurement uncertainty analysis, calibration intervals, calibration records, labeling, and out-of-tolerance analysis.
• Experience with statistical methodologies, including gage R&R, %P/T, %SV, and related statistical tools for measurement of system capability and method evaluation.
• Working knowledge of ISO 17025, ISO 10012, ISO 13485, FDA-regulated quality expectations, and audit support for calibration and measurement controls.
• Experience developing and reviewing ECS/ECP documentation, calibration procedures, supplier certificate reviews, and oversight of external calibration providers.
• Demonstrated ability to lead metrology functions, influence cross-functional teams, and drive metrology strategy, laboratory capability growth, and continuous improvement.
• English Level desired: B2+ (80–89%).
• Competencies: influence, decision-making, strategic thinking, communication, quality orientation, relationship building, and planning.

Requisition ID: 630739

As a leader in medical science for more than 40 years, we are 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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

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