About this role
Job Description
Support the development and manufacturing of medical products by performing product transfer as the team leader meeting deadlines and targets, validation, continue improvement and lean manufacturing activities including writing or verifying specifications, supporting R&D, maintaining key process indicators, designing fixtures, developing test for processes, equipment and raw materials to ensure that the concepts, process, products and/or prototypes meet their requirements. Experience in leading/coordinating interdisciplinary groups of Engineers and Techs. Job duties:- Carry out process transfers as a team leader, create strategies to ensure the success of the transfer in a timely manner.
- Manufacturing support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures.
- Driver/support on validation of product, equipment and processes, fixture design.
- Interface with other departments to solve production problems with the new products.
- Support the equipment maintenance program.
- Driver on investigation and testing of product processes as well Lean and Continues Improvement.
- Lead prototype and pilot production, facilities and planning activities, when appropriate.
- Lead manufacturing efforts associated with new product transfer between R&D and manufacturing, when appropriate.
- Perform additional duties and responsibilities as assigned.
Qualifications
- Degree in Engineering or related field.
- Minimum of five (5) years of related experience.
- Advanced English Proficiency: (B2+) minimum - (C1) ideal.
- PMP Knowledge or experience in transfer’s process.
- Ability to read and prepare technical/Validation documentation.
- Possess a working knowledge of standard machine shop equipment and processes.
- Knowledge of medical and technical development.
- Computer skills including Word, Excel, A-Cad or Solid Works, CMMS, Minitab, project.
- Ability to diagnose and repair electrical malfunctions on process tools and equipment.
- Knowledge of Statistics, DOE (Green Belt or Black Belt a plus).
- Extended periods of computer and microscope use.
- Extended periods of working in the clean room.
- Extended periods of sitting or standing.
- May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
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