January 26th, 2017

Product Development Engineer- Medical Devices & IVD Manufacturer, Los Angeles, CA

Product Development Engineer needed to oversee the development and manufacture of low cost, plastic devices including disposable blood collection devices.

Requirements

  • At least 5 years of experience in the development of medical devices
  • Bachelor’s degree in an engineering discipline preferred.
  • Mechanical and/or electrical engineering background
  • Experience in manufacturing, development, project management or commercial roles in a regulated (FDA, ISO) manufacturing environment.
  • Computer aided design (CAD) / SolidWorks or similar software package

Additional Expertise: Knowledge & Skills

  • Prototype design and testing
  • Risk Analysis, FMEA, and process validation
  • Design Verification, Product Validation and Usability (human factors) Testing
  • Injection molding
  • Selection of materials for medical devices based upon materials interface needs
  • Automation and Assembly of products
  • Design control

Essential Duties

  • Work with R&D on conceptualization, planning and design of new products
  • Identify, qualify, and supervise contract development firms and manufacturing partners
  • Organize new project/product quoting with outside firms
  • Assist in the development of budgets and product development timelines in Microsoft Project.
  • Manage develop programs and transfer to manufacturing under cGMP
  • Assist in the conceptualization of new products including providing modeling/design
  • Ensure documentation of product design (including specifications and tolerances)
  • Develop product requirements
  • Assist in the development of product Quality Control Plan
  • Inspection and auditing of contract manufacturers with team

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Contact:
Paul Dionne
MEIRxRS
pdionne@meirxrs.com

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