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    Product Transfer Engineer - Andover (MA), United States - Straumann

    Straumann
    Straumann Andover (MA), United States

    3 weeks ago

    Default job background
    Full time
    Description

    #ChangeMakers


    Ready to make an impact?

    We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

    We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others

    We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful "can-do" attitude.

    #WeChangeDentistry every day. Be part of it.

    POSITION SUMMARY
    The Product Transfer Engineer works closely with Quality and Manufacturing operations to implement technology transfers of Medical Devices into production. The position also supports continuous improvement projects that ensure compliance to product specifications and the quality system.

    JOB RESPONSIBILITIES
    This position is responsible for, but not limited to, the following:

    • Support design change and technology transfer activities for interplant transfers and new product introduction.

    • Coordinate and maintain change management process to ensure changes are reviewed with multifunctional teams and implemented within the plant to meet requirements of the Device Master Record.

    • Establish configuration of plant data packages in SAP Product Lifecycle Management (PLM). Ensure efficient creation and implementation of plant Quality, Engineering, and data packages per Straumann standards.

    • Development of quality plans and measurement procedures for the areas of incoming goods inspection and quality assurance. Develop and write processes and generate ECOs as required.

    • Drive qualification / validation efforts as defined in Validation Master Plan, including qualifying equipment, validating processes, data analysis, risk assessment, and monitoring of ongoing inspection activities. Provide complete, accurate, and well-organized documentation for requirements, plans, reports, PFMEA's, checklists, etc. in conjunction with the validation team.

    • Perform product and process evaluations to identify areas for improvement. Recommend solutions to identified problems; Implement approved changes using sound engineering principles and fully document them in compliance with QSR and ISO standards.

    • Other duties as may be assigned by the Head of Quality Engineering.

    MINIMUM QUALIFICATIONS

    • Bachelor's degree in engineering or related field

    • Minimum 5 years of experience as an engineer in a related field.

    PREFERRED QUALIFICATIONS

    • Working knowledge of validation, failure investigation, risk management, GR&R, auditing, quality assurance, and quality systems in a medical device environment.

    • Excellent knowledge of GMP and ISO standards.

    • Must be meticulous, conscientious, customer service-oriented, a team player-learner with strong written and oral communication skills.

    • The ability to work independently in a dynamic manufacturing environment.

    • Strong skills for planning, time management, organization and presentation.

    • Word, Excel, Project, statistical software computer skills.

    • Ability to develop project plans and execute to them. Experience leading multiple projects a plus.

    • Knowledge of database applications (SAP/PLM) is an advantage.

    • CNC machining experience a plus.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

    Employment Type: Full Time

    Alternative Locations: United States : Andover (MA)

    Travel Percentage: 0%

    Requisition ID: 13074

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