Senior Process Development Engineer

Senior Process Development Engineer
The successful candidate will be responsible for designing, developing, and validating robust, scalable processes & will provide direct line support to manufacturing operations, working closely with production teams to troubleshoot issues, stabilize processes, and maintain day-to-day performance.

Key Responsibilities:

• 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; analyze results, make recommendations, and prepare technical reports.
• Analyze 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.

Key Requirements:

• 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.
• Proficiency in statistical techniques (e.g., DOE, Six Sigma).