Senior Manufacturing Engineer, Validation

Cook Medical - Bloomington, IN

Full-time - Mid Level

Bloomington, IN

Merchant Wholesalers, Durable Goods

About the position

The Senior Manufacturing Engineer, Validation at Cook Inc. is responsible for performing and documenting validations of medical device manufacturing processes. This role is critical in ensuring that all manufacturing processes meet the required regulatory and company standards. The engineer will validate and implement medical device manufacturing processes as assigned, ensuring that all equipment and fixture installation qualifications are identified and met. Characterization of processes and their outputs, along with establishing acceptance criteria, is a key part of the role. The engineer will also be responsible for the written preparation of applicable validation reports that adhere to regulatory and company standards, ensuring that all documentation is accurate and timely. In addition to validation tasks, the Senior Manufacturing Engineer will engage in verification testing and project management, maintaining accurate reports and records throughout the process. The role requires excellent analytical and problem-solving skills, as well as a positive attitude and strong work ethic. The engineer must be self-motivated and capable of handling multiple projects simultaneously while working with minimal supervision. Continuous development and growth are encouraged, and the engineer must maintain all training requirements for the position. Effective communication and collaboration with various levels of the global organization are essential. The engineer must strictly adhere to safety requirements and maintain regular and punctual attendance, ensuring that company quality and quantity standards are met. The ability to remain calm and receptive in fast-paced situations is also crucial for success in this role.

Responsibilities

• Validate and implement medical device manufacturing processes as assigned.
• Identify equipment/fixture installation qualification requirements.
• Characterization of processes and their outputs/acceptance criteria.
• Written preparation of applicable validation reports that meet regulatory/company standards.
• Conduct verification testing.
• Manage projects effectively.
• Maintain accurate and timely reports and records.
• Demonstrate excellent analytical and problem-solving skills.
• Maintain all training requirements for the position and seek opportunities for continuous development and growth.
• Prepare and maintain accurate documentation consistent with pertinent regulations and Cook's Quality Management System.
• Interact effectively and professionally with others throughout various levels of the global organization.
• Strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Meet company quality and quantity standards.
• Communicate effectively and work in collaborative and independent situations.

Requirements

• Bachelor's degree in Engineering or Engineering Technology or related discipline.
• Minimum 5 years engineering experience in a regulated industry, preferably in a medical manufacturing environment; 7 years preferred.
• Experience using analytical skills and problem solving.
• Experience in communication and working with a wide variety of associates.
• Experience working independently and directing others towards a common goal.
• Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Engineering Server, Business Objects.