Job Title: Manufacturing Process Lead
We are seeking a highly skilled Manufacturing Process Lead to join our team. As a key member of our Operations department, you will be responsible for supporting and optimizing the manufacture of medical device products.
The ideal candidate will have a strong background in manufacturing process development and equipment management, with a proven track record of driving continuous improvement initiatives. You will lead manufacturing projects to develop, optimize, and validate production processes, collaborating with R&D and Quality teams to design and improve manufacturing procedures and workflows.
You will execute process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in line with the Quality Management System (QMS). Additionally, you will provide routine support to production operations, helping the team meet daily, weekly, and monthly manufacturing targets.
Troubleshoot and resolve product, process, and equipment issues in collaboration with QA and operations teams. Select, install, maintain, and monitor manufacturing equipment to ensure optimal performance.
Apply principles of Lean, Six Sigma, Statistical Process Control (SPC), and Key Performance Indicator (KPI) analysis to drive continuous improvement. Identify and implement cost-effective solutions to reduce cost of goods sold (COGs) as part of commercial readiness and scale-up plans.
This role requires a Bachelors degree (Level 8) in Engineering or a related field, with a minimum of 5 years' experience in the medical device industry. Proven expertise in manufacturing process development and equipment management is essential, along with a solid understanding of quality management systems (QMS), process controls, and regulatory compliance.
A strong problem-solving and analytical mindset, excellent communication skills, and the ability to liaise effectively with internal and external stakeholders are also required. Self-motivation, with a demonstrated ability to work both independently and within cross-functional teams, is essential. Strong organizational, presentation, and project management abilities are necessary for success in this role.