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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 (url removed)