Sr. Project Engineer

Responsibilities

• Assisting in the development of a world-class manufacturing group proficient in process improvement and problem-solving using Six-Sigma tools.
• Providing technical leadership on all product and process issues.
• Line performance monitoring and the compilation and execution of structured event plans to remediate systemic issues driving sub-optimal performance.
• Development and implementation of appropriate supporting documentation, SOPs, and process work instructions compliant with current Good Manufacturing Practices (GMP).
• Leading technical improvements under the business's Continuous Improvement Program (CIP).
• Transferring and implementing processes, either from development or from another manufacturing facility.
• Engineering support for new products and new processes, ensuring all activities are completed and documented in accordance with New Product Development Process.
• Process validation for products and processes, including IQ, OQ, PQ, and associated documentation.
• Conducting Gauge R&R studies for products and new processes.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Minimum of 5 years of experience in project engineering, preferably in a medical device manufacturing environment.
• Experience with Six Sigma methodologies and process improvement techniques.
• Strong understanding of Good Manufacturing Practices (GMP).
• Proven ability to lead and mentor teams in continuous improvement initiatives.
• Experience with process validation and documentation.
• Excellent communication and problem-solving skills.