Process Development Engineer
The process design engineer will support and ensure the efficient introduction of new product and processes into manufacturing on time and within budget to the company’s quality standards and agreed yield and efficiency levels, experience is process design using PFMEA. PMEA and DFM
Process Design: Support the interface between design and manufacturing on new product introduction and development ensuring project timelines are met and ensuring product/process is designed for manufacture (both maintenance and operation)
Process Design: FPMEA, FMEA, DFM develop and maintain assembly processes, jigs and fixtures working within project time and cost targets agreed for new product development.
Process design and Process Technology: Evaluate new concepts in relation to processes and manufacturing to fit in with Fundamental Technology Teams (FTT) and Manufacturing Technology Development Projects (MTDP), developing own expertise in designated area(s), and sharing this expertise with others in the business as required
Validation: PFMEA, FMEA, Perform necessary GMP (Good Manufacturing Practice), process validations and other quality system documentation requirements to support new product introduction and development.
Documentation: Prepare manufacturing documentation for above thus ensuring smooth transition into manufacturing. Maintain a record of all documentation, including drawings, sketches, calculations, records etc. ensuring a full history of process and product evolution is documented.
Compliance: Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP). Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook
Process design HNC or Degree in Mechanical engineering, Mechatronics or related field.
- Experience of Mechanical Design for Manufacture (DFM) , CAD, Fixture design, New Product Introduction PMEA, FMEA and Manufacturing support and improvements.
- Knowledge or experience of ISO13485 is desirable
- Knowledge or experience of medical devices and automation is desirable
- Experience of using process control tools and improvement techniques.
- Experience of labelling and packaging development and validation.
- Good understanding of various joining and assembly techniques.
- Line balancing.
- Lean manufacturing.
- Ability to read and understand technical drawings, awareness and understanding of tool room shop processes.