Endologix, Inc

  • Sr. Manufacturing Engineer

    Job ID
    2019-1990
    Location
    US-CA-Irvine
    Category
    Manufacturing
  • 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.

     

    Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

    Responsibilities

    • Design and develop manufacturing processes for new products and/or changes to existing products
    • Design and develop fixtures and tooling for manufacturing process
    • Develop and execute process validation protocols (IQ/OQ/PQ)
    • Analyze process data and make decisions/recommendations relating to process capability and DFM
    • Perform Installation Qualification (IQ) equipment protocols and reports
    • Investigate benefits and features of capital equipment and generate capital appropriation justifications
    • Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
    • Provide engineering support to production department in troubleshooting and resolving technical problems.
    • Contact and address component and/or raw material issues with suppliers
    • Support manufacturing and quality with addressing NCMR issues
    • Plan, schedule, and complete projects in a manner consistent with business objectives
    • Contribute to the intellectual property position of the company via invention and patent applications
    • Maintain accurate documentation of concepts, designs, and processes.
    • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
    • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
    • Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
    • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
    • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
    • Ensure that all regulatory and internal policies are followed
    • Assist engineering manager in development of engineers providing assistance with coaching and mentoring
    • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
    • Perform other duties as assigned by supervisor

    Qualifications

    • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
    • Has the ability to use moderate to advanced  statistic techniques when analyzing data and make rational and logical decision base the 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)
    • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.   
    • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

    Education:

    • Requires a Bachelor's of Science degree in Engineering or related technical degree (i.e. physics or mathematics)

    Experience:

    • Five years with a Bachelor's Degree, Three years with a Master's Degree of directly relevant subjects

    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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