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Amanda Pushko

Angestellt, Mechanical Design and Development Director, EndoChoice
Hamburg, Deutschland

Fähigkeiten und Kenntnisse

Lean Manufacturing
Continuous Improvement
Manufacturing engineering
Good Manufacturing Practice
Medical device
New Product Development
R&D
Sustaining Engineering
Qualification of equipment
FDA Regulation
ISO 13485
Root Cause Analysis
MS Office
Project management
Engineering Management

Werdegang

Berufserfahrung von Amanda Pushko

  • Bis heute 8 Jahre und 9 Monate, seit Sep. 2016

    Mechanical Design and Development Director

    EndoChoice

    Manage the Mechanical Engineering Department; responsible for developing, manufacturing and sustaining the world’s first full spectrum video endoscopy system. Serve as technical and project management lead, while ensuring adherence to design controls and product realization in accordance with ISO 13485, FDA and MDD. Worked to develop and improve department processes such as NPI and V&V. Main point of contact for department and project communication to the global organization as well as 3rd party experts.

  • 2 Jahre und 2 Monate, Juli 2014 - Aug. 2016

    Global Engineering Manager

    EndoChoice

    Managed the Manufacturing and Sustaining Engineering Department in EndoChoice GmbH, responsible for improving product reliability and quality. Developed a multidisciplinary international team workflow and communication structure to improve the process for executing global engineering projects. 30 projects were executed with results of a more than 200% increase in mean time between failures for product. Served as key leader in building a foundation for transforming EndoChoice into a Lean organization.

  • 1 Jahr und 10 Monate, Sep. 2012 - Juni 2014

    Manufacturing Engineering Manager

    Given Imaging

    Oversaw all Manufacturing Engineering projects and generated bi-monthly status reports for VP level; provided quarterly updates to COO. Effectively worked with international manufacturing locations and managed cross-site project coordination. Executed in depth Root Cause Analysis of product returns to develop and prioritize projects to improve product reliability, improvement of ~40%. Leader in the use of Lean Manufacturing methodology. Exceeded direct labor efficiency improvement targets of more then 10%

  • 1 Jahr und 4 Monate, Juni 2011 - Sep. 2012

    Manufacturing Engineer

    Given Imaging

    Worked with production and operations to increase production floor efficiencies by <20%. Implemented manufacturing best practices. Collaborate with team in Israel to develop semi-automatic production tooling; qualify and transfer tooling to production using IQ/OQ/PQ. Executed the qualification of alternate suppliers for improved yields, cost savings and critical component 2nd sources; yield improvement of <10%; cost savings of 50%. Project Management role in plant relocation qualification.

  • 1 Jahr und 5 Monate, Jan. 2010 - Mai 2011

    System Safety Engineer

    Northrop Grumman

    In all stages of the project, I oversaw large space and satellite programs from concept to launch, assuring that no person or hardware is, or can be, harmed in any way. I was responsible for generating System Safety Program Plans and Safety Data Packages as deliverables to the customer, including formally presenting these plans in design reviews. Also responsible for reviewing/approving all drawings, procedures, and documents for safety requirements.

  • 2 Jahre und 1 Monat, Mai 2007 - Mai 2009

    Graduate Research Assistant

    University of Southern California Material Science Department

    I worked on a research project for Jet Propulsion Laboratories, performing mechanical tests on a new composite material. These test included flexural and compressive tests, at varying environments using a programmable vacuum furnace. Executed additional material property tests such as micro-hardness and x-ray diffraction. I organized, prepared, and reported data to JPL as well as my advisor at USC. On down time, I work with my peers on projects involving pre-pregs, impact testing, ultrasound, etc.

  • 3 Monate, Juni 2006 - Aug. 2006

    Engineering Intern

    Goodrich Corporation

    As a summer engineering intern, I was in charge of developing a new screening method used for quality assurance. This was accomplished after performing both destructive and non-destructive tests on the product. In addition, I had to regularly prepared reports and presentations on my findings. I participated in daily meetings as well as meetings with customers.

Ausbildung von Amanda Pushko

  • 1 Jahr und 5 Monate, Jan. 2008 - Mai 2009

    Mechanical Engineering

    University of Southern California

    Material Science Research Assistant

  • 4 Jahre und 5 Monate, Aug. 2003 - Dez. 2007

    Biomedical Engineering

    University of Southern California

Sprachen

  • Englisch

    Muttersprache

  • Deutsch

    Grundlagen

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