Process Development Engineer

An innovative leader at the forefront of enhancing patient care worldwide are growing their NPI team in Cardiff. As a Process Development Engineer, you'll play a key role in evaluating new project requirements; conducting Design for Manufacturing (DFM) and Design for Assembly (DFA) studies, and optimising processes to help produce high-quality medical devices.

What You'll Do:

• Develop and Optimise Processes: Design and implement assembly processes, manage line setup, allocate equipment, and analyse data to ensure seamless transitions from NPI to production. You’ll lead initiatives to drive continuous improvement.
• 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.
   

Qualifications and Experience:

• 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 (e.g., FDA, MDR, EMA, ISO 13485)
   

This is a fantastic opportunity to be at the heart of innovation in medical device manufacturing. You’ll work in a hybrid role, with 3 days a week onsite, driving forward projects that directly contribute to enhancing patient care.
If you're within a commutable distance of Cardiff and eager to take on this challenge, please ‘Apply Now’ or contact Rachael for a confidential chat at r.maule@intapeople.com