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Staff Manufacturing Engineer NPD

Company: Endologix
Location: California City
Posted on: September 20, 2022

Job Description:

Overview

Staff level engineer responsible for the design and development of manufacturing processes, tooling, and fixtures in support of a next generation AAA and Peripheral devices. Support operations personel with sustaining products and collaborate with the R&D organization to help facilitate the successful execution of the New Product Development Process and launchingand supporting of robust products.

Responsibilities

  • Support operations in the daily output of existing products and processes.
  • Design and develop manufacturing processes for new AAA and Peripheral products.
  • Design and develop fixtures and tooling for new AAA and Peripheral products/processes.
  • Leader of the manufacturing development process with direct input into timelines and critical path items
  • Work with R&D staff to ensure that design for manufacturability principles are applied to new processes.
  • Plan, schedule, and complete projects in a manner consistent with business objectives.
  • Operations liaison for the project team responsible for communications to all appropriate operations groups.
  • Develop and execute process validation protocols (IQ/OQ/PQ).
  • Analyze process data and make decisions/recommendations relating to process capability and DFM.
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
  • 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.
  • Contact and address component and/or raw material issues with suppliers.
  • Contribute to the intellectual property position of the company via invention and patent applications.
  • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
  • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance.
  • Support company goals and objectives, policies and procedures, 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

    Education:
    • Requires a Bachelor of Science degree in Engineering or related technical degree (i.e. physics or mathematics)
      Experience:
      • Requires a minimum of 8-10 years related experience.
      • Experience with catheters and interventional delivery systems are required.
      • Knowledge in the following areas of manufacturing highly recommended, Balloon catheters, stent forming, PTFE, delivery systems, aseptic processing, pressure monitoring devices and injection mold design.

Keywords: Endologix, Lancaster , Staff Manufacturing Engineer NPD, Engineering , California City, California

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