Process Development Engineer
ICS Medical Devices | Full-time, Permanent
Job Summary
ICS Medical Devices is growing, and we are seeking a Process Development Engineer to support the development, validation, and optimisation of manufacturing processes for new and existing medical device products. This role is ideal for someone who enjoys contributing to innovation, applying structured problem‑solving, and collaborating to deliver high‑quality outcomes within a regulated environment.
Essential Duties & Responsibilities
Lead the development, optimisation, and scale‑up of manufacturing processes for New Product Introductions (NPI)
Plan and execute IQ/OQ/PQ validation activities in line with FDA, ISO 13485, MDR, and internal requirements
Prepare and maintain process documentation, including SOPs, Work Instructions, PFMEAs, and control plans
Conduct process capability studies and apply statistical tools such as SPC and DOE
Identify and implement process improvements to enhance product quality, efficiency, and yield
Troubleshoot process‑related issues and support effective CAPA activities
Collaborate with cross‑functional teams on product transfers and scale‑up initiatives
Contribute to risk management activities in alignment with ISO 14971
Maintain compliance with GMP, Health & Safety, and the internal Quality Management System
Required Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
3+ years of experience in process development within the medical device industry
Experience developing and scaling manufacturing processes in a regulated environment
Hands‑on experience with process validation (IQ/OQ/PQ)
Strong technical and analytical capabilities
Knowledge of Lean, Six Sigma, and continuous improvement methodologies
Understanding of regulatory standards such as ISO 13485, FDA cGMP, and MDR
Strong communication skills and attention to detail in technical documentation
Preferred
Lean Six Sigma certification (Green Belt, Black Belt, or equivalent)
Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA)
Benefits
Benefits:
Competitive Salary & Bonus
Private medical insurance
Additional Holidays
Sick pay
Occupational Pension Plan
Sports & Social Club
Cycle to Work & Taxsaver Commuter Ticket Scheme