Senior Manufacturing Engineer in the Medical Devices industry

We are hiring a Senior Manufacturing Engineer in the Medical Devices industry

We are looking for a highly skilled professional to drive the development, implementation, and continuous improvement of manufacturing processes. This role plays a critical part in ensuring compliance with product specifications, quality standards, and FDA regulations.

Key Responsibilities

• Perform installation and validation activities for production lines, including equipment, process, product, and test method validations, in compliance with regulations.
• Design and implement manufacturing processes, procedures, and production layouts for assemblies, equipment, and material handling.
• Support product improvements in areas such as risk management, test method validation, process validation, process control, supplier qualification, complaint investigations, CAPA, and process improvement.
• Execute and manage documentation in PLM systems (e.g., update DHRs, BOMs, work instructions, and create part numbers).
• Investigate and resolve production issues using structured problem-solving methods.
• Lead or support cross-functional manufacturing projects and initiatives.
• Provide guidance to engineering teams on design concepts and specifications to optimize manufacturing efficiency.
• Ensure compliance of processes and procedures with all applicable regulatory requirements.

We are seeking a results-driven engineer with a strong technical background and proven ability to lead complex manufacturing initiatives. If this opportunity aligns with your expertise, we encourage you to apply.

Requirements

Qualifications