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Manufacturing Engineer

Company: PEAK Technical Staffing USA
Location: San Jose
Posted on: August 8, 2022

Job Description:

PEAK is looking for a Manufacturing Engineer for a growing medical device client of ours in Silicon Valley. This position supports Production with Manufacturing Engineering activities related to sustaining existing product with a heavy emphasis on Contract Manufacturing management. Plans, directs, and coordinates outsourced production by managing Contract Manufacturers and logistics providers. Production manager for disposable and capital equipment made by Contract Manufacturers. Integrates second source Contract Manufacturers into existing product pipeline.

REQUIREMENTS:

  • BS degree in engineering with minimum of 3 years experience or AA with minimum of 5 years of production experience. Must have 3+ years of hands-on medical device company experience.
  • Must be able to multi-task and operate in a fast startup environment with minimal training and supervision.
  • Experience working with offshore Contract Manufacturer a plus.
  • Ability to read, analyze, and interpret manufacturing instructions, CAD drawings, spreadsheets, business memos, reports, technical procedures, and simple legal documents.
  • Ability to write protocols, reports, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers and customers. Ability to respond to general inquiries or complaints from production staff and other team members.
  • Ability to effectively present information to top management.
  • Word processing, spreadsheet, Internet, e-mail, manufacturing, MRP system and SolidWorks or other CAD.
  • QuickBooks inventory module experience is a plus. Job Requirements: RESPONSIBILITIES:
    • First point of contact for specification changes, manufacturing changes, end of life components, and quality issues for Contract Manufacturer. Responsibility to address the issue in a manner compliant with both internal and vendor quality system requirements assuring communication within both organizations.
    • Support field service personnel regarding part replacement or rework instructions.
    • Support internal production design control change assessment including repeat verification/validation testing if needed. Includes authoring of protocol, performing testing and authoring report.
    • Supports the manufacturing aspects of the design control process in compliance with all ISO, EN, MDD, MDR and FDA regulations and requirements.
    • Responsible for Production and managing production schedules of Contract Manufacturers, both domestic and offshore, to meet forecast.
    • Manages necessary logistics and coordination between international Contract Manufacturers, 3 rd party logistics/distribution partners and shipping entities to maintain the supply chain. Executes documentation compliant with the quality system necessary for these processes.
    • Provides staff with regular reports of stock, material usage and forecast build quantities. Reviews production forecasts to determine materials needs.
    • Proposes and executes purchasing of product to maintain stock required to fulfill forecast.
    • Responsible for understanding and maintenance of manufacturing documentation at Contract Manufacturer, to ensure product quality, cost, manufacturing, and delivery requirements are met.
    • Other responsibilities as needed to maintain Contract Manufacturer production or logistics.

Keywords: PEAK Technical Staffing USA, San Jose , Manufacturing Engineer, Professions , San Jose, California

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