Engineer II, Manufacturing Process

Position Overview

INNOVATION STARTS WITH YOU

Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.

Position Overview
  • Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
  • Supports validation of product, equipment and processes.
  • Interfaces with other departments to solve production problems.
  • Monitors equipment maintenance program.
  • Investigation and testing of product processes, NCR’s, DC’ and EO’s.
  • Drafts and executes validation of product, equipment and processes
  • Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning
  • Analyze data and improve processes to assure robust/repeatable manufacturing processes
  • Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes
  • Manage process validation and product transfer activities across different manufacturing facilities
  • Review and develop manufacturing documents (MP, Routers, BOM, etc.)

Job Details

  • Required Qualifications
    1. Bachelor of science in Mechanical or Bio-Medical Engineering or equivalent experience
    2. 3 to 5 years of related experience to include process development (process parameters development) and process validation experience.
    3. Medical device industry, prefer catheter products a big plus
    4. New product development
    5. SolidWorks
    6. Experience with IQ and OQ process validation
    7. Good communication skills.
    8. Computer skills including Word, Excel and PowerPoint
    Desired Qualifications
    1. Statistical Knowledge (Green Belt or Black Belt a plus).

    Additional Information
    • The primary work location for this position is Aliso Viejo, CA (company headquarters)
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.

    Comments
    MicroVention® TERUMO was founded in 1997, employs approximately 2,800 worldwide, and has experienced double-digit revenue growth year-over-year 3 years running. Recognized as one of the “Top Workplaces” in Orange County, California, we have a thriving culture that is innovative, customer-focused, clinically driven, demonstrates a team spirit, and empowers its employees to challenge the status quo. “MicroVention® TERUMO…Innovation Starts with You”.