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San Francisco Bay Area, CA

  • Quality Engineer – Equipment Calibration

    Position Overview

    The Sr. Quality Calibration Engineer is responsible for being the subject matter expert (SME) on calibration for all new and existing equipment used in Manufacturing and Development. Will collaborate with Quality, Manufacturing, and R&D Engineers on equipment requirements and will be responsible for creating, releasing, and maintaining calibration documents that define the specifications for all equipment. This position will be responsible for managing calibration activities with vendors and equipment manufacturers to ensure all equipment is calibrated accurately and on-time.

    Essential Job Functions

    • SME on calibration for all tools and equipment used in Manufacturing and R&D.
    • Support new product development projects with the creation and release of calibration
    • Collaborate with engineers to maintain and ensure that existing calibration documents are
    • accurate and up to date.
    • Manage both manual and automated calibration software systems to ensure tools and equipment are calibrated prior to use.
    • Coordinate with calibration vendors and equipment manufacturers to ensure all tools and equipment are calibrated prior to their calibration due dates.
    • Responsible for ensuring all post-calibration activities are performed, calibration and labeling requirements are met, and equipment is functioning properly before releasing for official use.
    • In the event of an out of tolerance condition, work cross-functionally to assess the risk and product impact, and to resolve the problem.
    • Support equipment calibration activities associated with the expansion of the manufacturing areas.
    • Manage/Lead improvement projects related to equipment calibration and calibration management systems.
    • Act as the on-site administrator for any calibration management software.
    • Work with the Manufacturing Engineering group to ensure Preventive Maintenance is performed as scheduled.
    • Maintain and ensure equipment files are accurate and up to date.
    • Review, monitor, and trend calibration results for periodic reporting, and proactively identify equipment problems and improvements.
    • May support operations and R&D with tooling, fixtures and prototypes for new and existing equipment used in the manufacture and development of company products.
    • May assist with evaluating and ordering equipment that best fits project requirements.
    • Work cross-functionally on root cause analysis to resolve equipment problems.
    • Train vendors and cross-functional team members as needed on equipment requirements.
    • May be required to support equipment validation activities.

    Requirements  

    • BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience .
    • Minimum 3 years of Engineering experience in manufacturing or development, working with equipment and calibration. Experience in Quality Engineering is preferred.
    • Minimum 2 years of experience working in a FDA regulated environment (medical devices) .
    • Experience with Balloon Catheters and Balloon Catheter Equipment
    • Experience and understanding of electronics/electrical systems is preferred.
    • Understanding medical device manufacturing and medical device manufacturing environment is preferred.
    • Experience in implementing an electronic/automated calibration management system is desired.
    • Must be able to read technical diagrams, schematics, blueprints, and equipment manuals.
    • Strong technical writing skills.
    • Must be able to effectively communicate with all levels of management and organizations.
    • Must be proactive, self-motivated, and work independently with minimal supervision.
    • Ability to work in a fast-paced environment, managing multiple priorities.


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