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
- Performance‑based bonus
- Healthcare cover from start date
- Occupational Pension Scheme from commencement
- Additional annual leave
- Employee assistance programme
- Employee discounts
- On‑site parking
- Bike to Work scheme
- Private medical insurance
- Sick pay
- Opportunities for ongoing professional development and career progression
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