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    Spine Packaging Engineer - Gurugram, India - ALTEN

    ALTEN
    ALTEN Gurugram, India

    1 week ago

    Default job background
    Upper Management / Consulting
    Description

    Job Description

    The Senior R&D Packaging Engineer (PE) will be a member on the NPD/Sustaining/EUMDR Packaging project teams with responsibilities for design and development of packaging components, MDR activities includes the notified body response, CE marking, design verification, and shelf-life testing.

    Requirements: Degree in Packaging, Industrial, Mechanical engineering, or applicable technical field.

    • 5- 8 years of relevant experience in a highly regulated industry, with relevant experience in design and developing best in class packaging solutions from early concept through commercialization for sterile and non-sterile medical devices.
    • Develop packaging components that improve the customer experience, working with a drafter to develop 3D models.
    • Work cooperatively with quality, manufacturing, regulatory, clinical, marketing, R&D device designers, supply chain, vendors, and kitting centers – across geographies -- to ensure project success.
    • Build Quality into all aspects of product development to support compliance to all requirements and leading improvements and development of solutions that make it easier for the organization to maintain compliance in complex areas (such as ever-evolving regulatory requirements worldwide).
    • Support audits, non-conformances and CAPAs as needed.
    • Lead small- scale Packaging projects or co-manage large-scale programs to drive changes across the portfolio.
    • Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates.
    • Role model a high level of service and responsibility in managing a high and varied workload from internal clients and working to tight timelines.
    • Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training.
    • Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (ISO 11607/13485/14971, ASTM, ISTA).
    • Familiarity with ASTM packaging standards, Blister, Tray, Form-Fill-Seal, and heat-seal operations is desirable.
    • Familiarity with various packaging materials and their characteristics required.
    • Understanding of various sterilization processes is desirable.
    • Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements.
    • EU MDR activities includes the notified body response for technical documentation and remediation activities.
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