Principal Manufacturing Engineer

at Endologix
Location Milpitas, California
Date Posted July 31, 2022
Category Engineering
Job Type Not Specified

Description

The people here don t just create products - they create solutions that will help save lives and revolutionize the industry. It s the diversity of thought and passion of those people that inspire innovation in everything we do. Be part of the change.

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. In addition, Endologix will provide reasonable accommodations for qualified individuals with disabilities. If you'd like more information about your EEO rights as an applicant, please click here .

Click here to view Endologix Affirmative Action and Equal Employment Opportunity Policy Statement

Engineer responsible for the design and development of manufacturing processes, tooling, and fixtures in support of a next generation AAA and peripheral devices. Collaborate with the R&D, Operations, and Quality organizations to help facilitate continuous support of production to existing products and support the successful execution of the New Product Development Process and launching of robust products.

Responsibilities

  • Develop and execute process validation protocols (IQ/OQ/PQ).
  • Support ongoing production 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 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.
  • 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 8-12 years related experience.
  • Experience with catheters and interventional delivery systems is required.
  • Knowledge in the following areas of manufacturing highly recommended, Balloon catheters, stent forming, PTFE, aseptic processing, pressure monitoring devices and injection mold design.

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