Senior NPI Engineer (Medical Device)

Key Responsibilities:

• Manage NPI projects and convert customer requirements into detailed internal specifications.
• Develop and establish product and raw material specifications for new and existing products.
• Design and validate tools, jigs, and fixtures for automated, semi-automatic, or manual production processes.
• Support manufacturing setup, including process design, cycle time calculation, and line balancing.
• Prepare key documentation such as BOMs, test methods, inspection standards, and SOPs for new products and processes.
• Troubleshoot production issues and support process optimization and validation activities.
• Conduct training for production teams to ensure proper understanding and implementation of new processes.

Key Requirements:

• Bachelor's Degree in Engineering or Science.
• Minimum 3 years of experience, preferably in a manufacturing or medical device environment.
• Hands-on experience in project management, product, and process development.
• Proficient in CAD software (SolidWorks preferred).
• Knowledge of statistical analysis and manufacturing validation practices.
• Familiarity with ISO 13485 and GMP standards is an advantage.
• Proactive, eager to learn, and able to work independently or in a team.