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Gurgaon

    Senior Design Engineer-Packaging NPI - Gurugram, India - ALTEN

    ALTEN
    ALTEN Gurugram, India

    Found in: Talent IN 2A C2 - 20 hours ago

    Default job background
    Upper Management / Consulting
    Description

    Responsibilities and duties:

    • with technical SMEs, Global packaging Design team and Global vendors and develop Packaging components for Trauma Extremities Projects.
    • technical ability in creating/reviewing Engineering drawings and models and having hands on experience on Creo/SolidWorks etc.
    • and conduct preliminary feasibility design testing for all new packaging design/concepts.
    • technical knowledge in materials, manufacturing processes and DFM applied to test, analyse, and optimize design.
    • closely with the Packaging NPI team peers, R&D Hardware, BML, Quality, Operations, Regulatory, Clinical, Marketing, Labeling and vendor across geographies to ensure project success and improve the customer experience.
    • Audits, Non-Conformances and CAPAs as needed.
    • Good Document practices (GDP) for all documentation created and staying current on all required training.
    • understanding of Design Controls procedures and Industry standards in Medical Device Packaging Design and Testing.
    • team values and demonstrate enthusiasm and commitment to the Packaging Groups organizational vision, high degree of participation in problem solving and decision making both locally and globally.
    • frequently across all project disciplines to ensure project team and senior management are aware of upcoming milestones and risks/issues.
    • communication and knowledge of compliance regulations and standards including IS &2, 21CFR820, ISO13485 and ISO14971 throughout the design and development process.

    Experience/Skills required:

    1. in Packaging/Mechanical Engineering.
    • years of relevant work experience.
    • understanding of design of medical device Packaging and Labeling.
    • understanding of Design Verification and Validation and Design review process as per the requirement.
    • good knowledge of the Packaging material selection for different levels of packaging.
    • on the PLCM softwares like Windchill/SAP etc.
    • technical ability in understanding of DFM/DFI.
    • have excellent Interpersonal and Communication skills.
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