Engineer I, Manufacturing Process

Position Overview

Support manufacturing process development and manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts, sub-assemblies, finished products, and/or prototypes meet requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch. Job duties:
  • Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures.
  • Support validation of product, equipment, and processes.
  • Interface with other departments to solve production problems.
  • Monitor equipment maintenance program.
  • Investigation and testing of product processes.
  • Support prototype and pilot production, facilities, and planning when appropriate.
  • Draft and execute validation of product, equipment, and processes.
  • Manage 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.
  • Manage process validation and product transfer activities across different manufacturing facilities.
  • Review and develop manufacturing documents (MP, Routers, BOM, etc.).
  • Perform additional duties and responsibilities as assigned.

Job Details

Job ID 11317BR

Alajuela, Costa Rica

    1. Bachelor of Science in a related field (e.g., ME, BSChe, EE, IE, PE, etc.).
    2. Strong written and verbal communication skills.
    3. Computer skills including Word, Excel, and PowerPoint.
    4. Proficiency in SolidWorks (and/or CAD) and fixture/tooling design.
    5. Ability to read and prepare technical documentation.
    6. Working knowledge of standard machine shop equipment and process.
    Desired Qualifications
    1. Knowledge of Process Validations in medical device manufacturing environment.
    2. Good problem solving and conflict management skills.
    3. Knowledge of medical and technical development.