Key Responsibilities:
- Tooling and equipment transfer, IQ/OQ’s, facilities modifications, process mapping (including equipment installation, process characterization, calibration activities, spare part list, establish min-max system in the tool crib, etc.)
- Once the transfer is completed is responsible for supporting the implementation of manufacturing procedures and for providing training to production trainers.
- Create product structures based on Sending Facility information.
- Coordinate the Process Flow Chart and cell layout with the Industrial Engineer.
- Equipment and tooling list and place the purchase requisitions.
- Create and execute the IQ/OQ protocols and reports, perform and document laboratory notebook studies.
- Support in the execution and/or follow up of special production orders for new product launches. Support in the developing of manufacturing processes.
- Provide support on creating the DMR documentation (BOMs, routings, manufacturing procedures, product drawings, tooling drawings, raw material specifications, etc.)
- Participate actively in the Device Master Record (DMR) reviews, CR’s reviews and collaborate in all activities with Quality Engineering related with the transfer.
- Support the implementation of manufacturing procedures and train the production trainers. Supervise technicians; provide guidance, support, and feedback.
- Design of fixtures for new manufacturing processes.
- Participate in budget activities and has controls over expenses with the areas under their supervision.
Qualifications:
- Bachelor’s degree in manufacturing, industrial, mechanical, electronic engineering.
- A master’s degree, Six Sigma and/or Lean manufacturing certification are desirable.
- Capable to use problem solving methodologies and statistical tools.
- SolidWorks or other CAD experience (preferred)
- Able to communicate both verbally and writing in English.
- 2 years on Manufacturing Operations
- Good communication skills.