Endologix, Inc

  • Senior Quality Engineer - Packaging

    Job ID
    2018-1927
    Location
    US-CA-Irvine
    Category
    Quality
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

    Quality Engineer responsible for leading the development and design of all new packaging products in support of New Product Development and current manufacturing.

     

    Responsibilities

    Primary duties for the Quality Engineer – Packaging include:

    • Resolution of packaging issues following standard problem solving techniques
    • For new programs, lead Package design, development, validation and implementation for packaging configurations.
    • Responsible for including design for manufacturing requirements to ensure the manufacturing packaging process is reproducible with minimal impact to packaging operators.
    • Responsible for packaging equipment validation (IQ/OQ/PQ) activities, including design of experiments with materials and sealing equipment.
    • Testing and validation of all new / modified packages.
    • Coordinate with Production, Supplier Quality, Regulatory and Supply Chain to implement new packages and/or new packaging equipment.
    • Lead cross functional activities (primarily Marketing, Clinical and R&D) to establish packaging design requirements.
    • Manage external suppliers on packaging designs and material lead times for validation to ensure on time, on budget execution.
    • Lead manufacturing training for new packaging configurations and or updates.
    • Maintain an up‑to‑date knowledge in the areas of Packaging Engineering, Quality Assurance, Regulatory Compliance, Design Controls, and Statistical Techniques. Maintain an up‑to‑date knowledge of the company products, policies, and procedures

    Documentation & Drafting Services:

    • Execute technical product documentation (drafting, modeling, procedures, etc.) to support project completion per timelines.
    • Identify opportunities and implement best practices.
    • Technical writing ability in relation to drafting specifications, protocols, reports, etc.
    • Support company goals and objectives, policies and procedures, and all applicable regulations

    ADDITIONAL JOB DUTIES:

    • Perform other duties as assigned by supervisor.

     

    Qualifications

    • Strong knowledge of ISO and ASTM requirements and how it relates to packaging verification and validation activities
    • Technical knowledge of the company’s packaging as it relates to ISO 11607-1 and 11607-2 requirements
    • Experience with HDPE cards, HIPS tray, Tyvek pouches, and other packaging materials.
    • Experience with catheter and interventional delivery system packaging is required.
    • Preferred experience to include; Cold Chain, GS1 Compliance, RFID and sterilization methods (EtO, VHP, Gamma and E-Beam)
    • ASQ CQE Certification desired, however will train the right candidate.
    • Uses appropriate statistic techniques for data analysis and makes rational and logical decisions based on that analysis.
    • Applicable knowledge of Minitab, JMP, or other statistic tools.
    • Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill).
    • Ability to handle multiple tasks simultaneously and ability to manage project timelines
    • Must be accurate in handling detailed information/data and able to effectively communicate those data to drive decisions
    • Flexibility and willingness to learn and be developed in the medical device quality engineering and packaging field

    Minimum Education:

    • Requires a Bachelor of Science

    Minimum Experience:

    • Requires minimum 6 years of related Quality Engineering experience supporting packaging design and production processes
    • Experience with implantable medical device packaging design and production processes strongly preferred

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

     

     

     

     

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