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    General Engineering Application - Natick, MA, United States - Michael Page

    Michael Page
    Michael Page Natick, MA, United States

    2 weeks ago

    Michael Page background
    Description

    In this Sustaining Engineering Manager role you will be responsible for managing all technical aspects of product design and manufacturing operations.

    This will include product enhancements, lifecycle management, and resolution of technical issues, while maintaining strict adherence to regulatory requirements and quality standards.

    My client is a rapidly growing Boston-based medical device company dedicated to improving healthcare outcomes through innovative medical technologies. They are continuing to develop new solutions for the treatment of diseases with unmet medical needs.
    The Sustaining Engineering Manager will report directly into the Director of Operations and Engineering and be responsible for:
    Oversee the resolution of technical issues related to existing products, ensuring product quality and reliability.
    Collaborate with cross-functional teams including R&D, Quality, and Manufacturing to implement design changes and product improvements.
    Develop Validation protocols, including IQ/OQ/PQ and working closely with Quality and Production.
    Drive continuous improvement initiatives to enhance product reliability, manufacturability, and cost-effectiveness while meeting regulatory and quality requirements.
    Act as the primary technical interface with contract manufacturers.
    Own and maintain the Design Controls documentation package for Class II and III medical devices.

    Apply today for immediate consideration
    Bachelors Degree in Engineering (Masters in Engineering or MBA is a plus)
    ~6-10 years of experience in a Medical Device Engineering
    ~Project Management knowledge and skills
    ~ Knowledge of continuous improvement, lean and six sigma tools (greenbelt preferred)
    ~ Must have AutoCAD and SolidWorks experience
    ~ Knowledge of FDA, ISO, EU and other relevant regulatory environments
    ~ Career growth opportunities
    ~ MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
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