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Product Support Engineer

Company: Apex Systems
Location: Irvine
Posted on: October 11, 2019

Job Description:

Job Description

Job #: 1010472

Product Support Engineer

Lake Forest, CA

Job Description


  • The successful candidate will be responsible for completing work requests as assigned by engineering teams and management.
  • This positon will provide needed support to Manufacturing project requests (cost improvements, obsolescence, corrective actions) for electromechanical/mechanical post market products:


    • Analyze and troubleshoot design and process changes, document impact on product design to support electrical/electromechanical design and process changes, complaint and risk analysis, technical file and product compliance documentation for Surgical Instrumentation products.
    • This position will also support project activities required for compliance to new European Medical Device Regulation (MDR), including managing and reporting technical product data, materials remediation, labeling updates and technical file updates (required to maintain European registration (CE mark) and will work to maintain product compliance to existing and future regulations and product test standards and reporting (EN, ISO, etc.)


      Skills:


      • 5+years of experience ideally in the medical device industry
      • Experience with product Verification & Validation
      • Medical Device Design Control including risk assessment, management and reporting
      • Experience with Corrective and Preventative Action (CAPA) including root cause analysis, problem solving and redesign of devices to meet requirement
      • Familiar with PRO-E and other Windchill product data management applications is preferred
      • Excellent written and spoken communication skills
      • Proficient in MS Office applications


        Education:


        • Bachelor's Degree or
        • Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
        • The ability to fluently read, write, understand and communicate in English

          If interested, please send your resume to Schuyler Harris

          sharris@apexsystems.com

          949-623-0003

          EEO Employer

          Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.

Keywords: Apex Systems, Irvine , Product Support Engineer, Engineering , Irvine, California

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