Senior Process Development Engineer
1 week ago
About the Role:
We are seeking a highly skilled and experienced Process Development Engineer to join our NPI team in Cardiff. As a key member of our team, you will play a crucial role in evaluating new project requirements, conducting Design for Manufacturing (DFM) and Design for Assembly (DFA) studies, and optimizing processes to ensure the production of high-quality medical devices.
Key Responsibilities:
- Process Development and Optimization: Design and implement assembly processes, manage line setup, allocate equipment, and analyze data to ensure seamless transitions from NPI to production.
- Process Validation: Ensure all processes comply with Good Manufacturing Practice (GMP) and adhere to all quality system documentation standards.
- Documentation and Compliance: Maintain detailed manufacturing documentation and technical reports, ensuring all work aligns with company quality standards and regulatory requirements, including Good Documentation Practice (GDP) and GMP.
Requirements and Qualifications:
- HNC or Degree in Mechanical Engineering, Mechatronics, or a related field / strong relevant experience.
- In-depth knowledge of medical manufacturing processes, technologies, and equipment.
- Experience in Mechanical Design for Manufacture, CAD (SolidWorks), fixture design, and New Product Introduction (NPI).
- Proficiency with process control tools, improvement techniques, and data analysis.
- Familiarity with various joining and assembly techniques, lean manufacturing, and regulatory standards.
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