Validation Engineer / Leader

Responsibilities:

• Establish performance and quality criteria for processes.
• Design and conduct validation tests.
• Analyze test data and document results.
• Evaluate production systems and processes for functionality, safety, and performance.
• Identify areas for improvement and recommend corrective actions.
• Troubleshoot and resolve system-related issues.
• Collaborate with engineers and technicians.
• Lead and oversee process validation activities.
• Manage and execute engineering project activities.

Requirements:

• Extensive experience in validation engineering, development, or a related role within the medical device industry, with leadership experience in Class II/III devices.
• Deep expertise in validation processes, PFMEA, test method validation, and quality management systems. Proven ability to lead and approve projects focused on process capability, risk management, and continuous improvement.
• Strong product development or engineering foundation, with additional experience in design and quality roles.
• Proficiency in statistical analysis tools and ability to drive data-driven decisions.
• Demonstrated leadership in guiding multidisciplinary teams, with excellent problem-solving and communication skills.
• Bachelor’s or Master’s degree in Materials, Mechanical, Electrical Engineering, or a related field. Advanced degrees or relevant certifications are a plus.