Job Specification: Process Manufacturing Engineer (Medical Device)

Role Overview

We are seeking a Process Manufacturing Engineer with experience in the Medical Device or Pharmaceutical sector. The role will support manufacturing processes, with a strong focus on packaging systems, automation, equipment, and process validation. This position will play a key part in introducing a new product, ensuring all packaging elements, equipment, and processes meet regulatory, quality, and performance expectations.

Key Responsibilities

Packaging & Process Ownership

• Lead and manage packaging processes including trays, sealing, sterilisation, labelling, and printing systems.
• Oversee the development, optimisation, and validation of packaging workflows and equipment.
• Ensure compliance with medical device / pharma regulatory standards (ISO 13485, FDA, GMP, etc.).

Equipment & Systems

• Support selection, introduction, and qualification (IQ/OQ/PQ) of manufacturing and packaging equipment.
• Troubleshoot and improve performance of systems and automation equipment within manufacturing lines.
• Collaborate with equipment vendors and internal engineering teams as needed.

New Product Introduction (NPI)

• Support NPI activities, ensuring smooth transfer of new products into manufacturing.
• Lead process validation activities associated with new product packaging and manufacturing workflows.
• Contribute to risk assessments, process documentation, and design transfer deliverables.

Process Improvement & Validation

• Conduct process validations for packaging, automation, and manufacturing steps.
• Drive continuous improvement initiatives to enhance safety, efficiency, and product quality.
• Maintain complete and accurate technical documentation.

Experience & Skills Required

• Background in Medical Devices, MedTech, or Pharmaceuticals (highly preferred).
• Experience with packaging processes such as trays, sealing, sterilisation, labelling, and print systems.
• Hands‑on exposure to manufacturing equipment, automation, and system troubleshooting.
• Strong understanding of validation requirements: equipment qualification, process validation, and documentation.
• Experience supporting NPI, equipment transfers, and introduction of new systems or processes.
• Knowledge of relevant regulatory frameworks (GMP, ISO 13485, FDA/QSR, EU MDR).