Assembler II, Validation
Perform the testing of medical device products in an entry-level position under close supervision from R&D/Manufacturing Technician or Validation Engineer in accordance with test methods. Job duties:
- Set up test equipment and perform testing of products per test procedures and/or protocols. Examples of test procedures include: Simulated Use test, iIstron test, Radial Force test, Burst test, Pouch Seal test, Fatigue test, visual and dimensional inspection, etc.
- Record data associated with the testing of products.
- Communicate with immediate supervisor and/or Subject Matter Experts (SME) when issues related to test materials, equipment, and/or written procedures are encountered.
- Follow all related quality, compliance, and company policies and procedures.
- Understand operations objectives and work with team members to achieve overall test goals.
- Learn and maintain knowledge and skills to perform test procedures successfully.
- As directed by Validation Engineer and/or SME, perform hands-on training to other Assemblers on test procedures.
- Meet all performance standards and metrics by using time and resources efficiently.
- Maintain a safe and clean working environment by keeping work area in a neat and organized manner.
- Must be willing to work overtime when needed.
- Other duties as assigned or required.
- HS diploma or equivalent.
- General knowledge of clean room procedures.
- Previous experience using microscopes.
- Minimum two (2) years of manufacturing/testing experience, preferably in the medical device industry.
- Knowledge of basic measurement tools including scales, rulers, US and metric measurement.
- Ability to work with multiple test equipment and procedures.
- Ability to set up and operate test equipment.
- Ability to read engineering drawings.
- Ability to clearly and effectively communicate with Technicians, Engineers, and Managers.
- Basic math and computer skills (Microsoft Excel, Word).
- Ability to work in a culturally diverse work environment.