Process Engineer

About the Role

We are seeking an experienced Process Engineer to join our innovative Med Tech company on a 12-month fixed-term contract. Specialising in cutting-edge orthopaedic products, we are at the forefront of medical device manufacturing, utilising advanced laser-based additive manufacturing technologies to deliver life-changing solutions to patients.

This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing.

• Lead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirements
• Develop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologies
• Conduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standards
• Drive continuous improvement initiatives to optimise process efficiency, quality, and compliance
• Collaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturing
• Prepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating procedures
• Support investigations and implement corrective and preventive actions (CAPA) for process-related non-conformances
• Ensure all processes meet stringent regulatory requirements for medical device manufacturing

• Validation:
  Proven experience in process validation (IQ/OQ/PQ) within a regulated manufacturing environment
• Med Tech Regulatory Knowledge:
  Strong understanding of ISO 13485 Quality Management Systems
• FDA Compliance:
  Working knowledge of FDA Code of Federal Regulations (CFR), particularly 21 CFR Part 820
• Advanced Manufacturing:
  Hands-on experience with laser-based additive manufacturing processes
• Risk Management:
  
  Demonstrated expertise in PFMEA methodologies and ISO 14971 risk management

• Experience with orthopaedic or implantable medical devices
• Knowledge of additional additive manufacturing technologies
• Familiarity with design controls and design history file requirements
• Experience with statistical process control and data analysis tools