Senior Process Development Engineer

The Senior Process Development Engineer will be responsible for designing, developing, and validating robust, scalable processes that ensure our medical devices are produced safely, effectively, and in compliance with all applicable regulations. In addition to leading key development projects, this role will provide direct line support to manufacturing operations, working closely with production teams to troubleshoot issues, stabilize processes, and maintain day-to-day performance. The role will also contribute to building the foundational systems, documentation, and operational culture needed to support sustained growth.

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• Collaborate with engineers and production teams to develop and improve manufacturing processes.
  
• Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives while scaling up output to meet required annual growth rates.
  
• Lead automation initiatives, from conceptual design through implementation, ensuring seamless integration with existing manufacturing processes and full compliance with quality and regulatory standards.
  
• Identify and drive implementation of process improvements using Lean methodologies.
  
• Apply structured problem‑solving techniques to process, material, or equipment issues, offering manufacturing or quality solutions from experience.
  
• Develop and maintain operational processes and procedures that reflect industry best practices and comply with relevant regulatory requirements.
  
• Perform process analysis and identify areas for improvement, including the evaluation and implementation of automation technologies (e.g., vision systems, robotics, digital monitoring) to enhance productivity, efficiency, and process reliability.
  
• Develop complex experiments and validation protocols; analyse results, make recommendations, and prepare technical reports.
  
• Analyse and resolve complex manufacturing and compliance issues (e.g., CAPA, non‑conformances, audit observations).
  
• Develop training materials and documentation (e.g., work instructions) to ensure effective knowledge transfer to production teams.
  
• Work with internal stakeholders to explore and assess new technologies in terms of performance, cost, and reliability.
  
• Actively engage in and support daily manufacturing operations.
  

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• Level 8 degree in Engineering or related discipline, with 5+ years of relevant experience.
  
• Green Belt certification is a distinct advantage.
  
• Proven experience in medical device process development, manufacturing, and project/program management.
  
• Strong skills in risk analysis, problem‑solving, and process validation (equipment and manufacturing).
  
• Dynamic team player with proactive ownership of tasks and projects.
  
• Excellent organizational and interpersonal skills.
  
• Solid understanding of Lean principles and tools (e.g., DMAIC, Kaizen, Value Stream Mapping).
  
• In‑depth knowledge of ISO 13485 and FDA regulatory requirements. xcfaprz
  
• Proficiency in statistical techniques (e.g., DOE, Six Sigma).