Principal Supplier Quality Manufacturing Engineer

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POST DATE 8/12/2016
END DATE 10/11/2016

Endologix, Inc. Irvine, CA

Company
Endologix, Inc.
Job Classification
Full Time
Company Ref #
2016-1553
AJE Ref #
575859680
Location
Irvine, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
OVERVIEW:

Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.





Engineer responsible for the design, development, and improvement of the next generation of AAA devices with specific focus on component qualification and supplier related activities. Collaborate with R&D, NPD, Quality-DAE, QA/QEIQC, Regulatory, Supply Chain and Operations-Production to help facilitate the successful execution of the new product development process and launching of robust products.

RESPONSIBILITIES:

* Analyze data and make decisions/ recommendations relating to process capabilities, including Supplier processes.

* SME for technical interactions with suppliers regarding molding, extrusion, components/ raw materials.

* Develop and/or improve manufacturing processes for Endologix products by making data driven decisions and utilizing lean and six sigma principles.

* Design and develop fixtures and tooling for Endologix products/ processes.

* Lead or act as a SME for supplier/component related projects by establishing or providing input to project timelines, executing project tasks, and reporting on project status to management.

* Plan, schedule, and complete projects in a manner consistent with business objectives.

* Operations liaison for the project team responsible for communications to appropriate operations groups.

* Develop and execute Supplier Process Validation protocols (IQ/OQ/PQ/PPQ).

* Create and maintain accurate documentation of concepts, designs/ drawings, testing and work orders.

* 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 management in development/ coaching/ mentoring of junior engineers and technical staff in areas of component qualification, process qualification, and manufacturing processes.

* Identifies hazards and mitigates risk associated with identified hazards in Supplier Process FMEA.

QUALIFICATIONS:

* Works on complex problems in which statistical data analysis, with various factors, is required.

* Exercises technical judgment in selecting methods, techniques, and evaluation criteria for obtaining results.

* 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

* Excellent verbal and written communication skills



Education:

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

Experience:

* Requires a minimum of 8+ years related experience.

* Experience with catheters and interventional delivery systems is required.

* Knowledge in the following areas of manufacturing highly recommended; Molding & design, Extrusion, Injection molding & design, Balloon/ Balloon catheters, Stent fabrication & forming, Materials (i.e. PTFE, PeBax, Polyurethane, etc.), Aseptic processing, and medical device manufacturing

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.