The Senior Process Development Engineer will be responsible for the design, development, optimisation, and validation of robust and scalable manufacturing processes for medical devices. The role will support both new product/process development and day‑to‑day manufacturing operations, ensuring products are produced safely, efficiently, and in compliance with all applicable regulatory and quality standards.
The successful candidate will lead key development initiatives, provide technical support to production teams, troubleshoot process‑related issues, and contribute to continuous improvement activities. This position will also play a key role in establishing systems, documentation, and operational practices to support long‑term organisational growth.
Key Responsibilities
Design, develop, optimise, and validate manufacturing processes for medical device production
Lead process development and continuous improvement projects from concept through implementation
Provide direct technical support to manufacturing operations and production teams
Troubleshoot process, equipment, and production issues to maintain operational performance
Develop and maintain process documentation, validation protocols, and standard operating procedures (SOPs)
Ensure all processes comply with regulatory, quality, and safety standards
Support process transfers, scale‑up activities, and new product introductions (NPI)
Analyse process data to identify trends, improve efficiency, and reduce variability
Collaborate cross‑functionally with Quality, Manufacturing, R&D, and Supply Chain teams
Participate in risk assessments, root cause investigations, and corrective/preventive actions (CAPA)
Contribute to building operational systems and best practices to support company growth
Required Qualifications & Experience
Bachelor’s degree in Engineering or related discipline
Experience in process development, manufacturing engineering, or medical device/pharmaceutical manufacturing
Strong understanding of process validation and regulatory compliance requirements
Experience supporting manufacturing operations in a regulated environment
Knowledge of Lean Manufacturing and continuous improvement methodologies
Strong analytical, troubleshooting, and problem‑solving skills
Excellent communication and cross‑functional collaboration abilities
Preferred Skills
Experience with medical device manufacturing processes
Knowledge of GMP/cGMP and FDA/ISO standards
Experience with statistical analysis and process capability tools
Ability to work effectively in fast‑paced manufacturing environments
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