Process Development Engineer

Overview

ICS Medical Devices is expanding and looking for a Process Development Engineer to drive the advancement, validation, and enhancement of manufacturing processes related to new and current medical device products. This role is suited for a professional who thrives on innovation, structured problem-solving, and teamwork to achieve superior outcomes within regulated environments.

Key Responsibilities

• Lead efforts to develop, optimise, and scale manufacturing processes for New Product Introductions (NPI).
• Plan and conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation activities adhering to FDA, ISO 13485, MDR, and company standards.
• Create and manage process documentation such as Standard Operating Procedures (SOPs), Work Instructions, Process Failure Mode and Effects Analysis (PFMEAs), and control plans.
• Perform process capability analyses and apply statistical tools including Statistical Process Control (SPC) and Design of Experiments (DOE).
• Identify opportunities and implement process improvements to enhance product quality, productivity, and yield.
• Investigate and resolve process-related challenges and support Corrective and Preventive Actions (CAPA) effectively.
• Work collaboratively with cross-functional teams during product transfer and scale-up activities.
• Participate in risk management efforts aligned with ISO 14971 standards.
• Ensure compliance with Good Manufacturing Practices (GMP), Health and Safety regulations, and the internal Quality Management System.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or a closely related discipline.
• Minimum of three years' experience in process development within the medical device sector.
• Proven expertise in developing and scaling manufacturing processes within regulated settings.
• Practical experience executing IQ/OQ/PQ validations.
• Strong analytical and technical skills.
• Familiarity with Lean, Six Sigma, and continuous improvement techniques.
• Understanding of regulatory requirements including ISO 13485, FDA cGMP, and MDR.
• Excellent communication skills and meticulousness in technical documentation.

Preferred Skills

• Possession of Lean Six Sigma certification such as Green Belt or Black Belt.
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.

Benefits

• Competitive salary with bonus opportunities.
• Private medical insurance coverage.
• Additional holiday entitlement beyond statutory requirements.
• Paid sick leave.
• Occupational pension scheme participation.
• Access to sports and social clubs.
• Participation in Cycle to Work and Taxsaver Commuter Ticket schemes.