We are seeking an experienced Staff Process Development Engineer to join our client in Galway, Ireland.
Key Responsibilities:
* Design, develop, and optimize manufacturing processes for innovative medical devices, ensuring compliance with industry regulations.
* Further develop company methodologies to standardize and optimize steps for process characterisation, process development, and industrialization.
* Drive process improvements, lead technical projects, and act as a mentor to junior team members.
Process Development:
* Further development of a standard approach to process development.
* Process and material benchmarking: Evaluate and implement state-of-the-art technologies, materials, and methods to optimize manufacturing operations.
* Achieve through benchmarking research network development vendor and education centers.
* Scale up processes from pilot-scale to full-scale production, ensuring robustness and repeatability.
Regulatory Compliance:
* Develop and maintain process documentation in compliance with regulatory requirements.
* Support regulatory submissions by providing process data, validation protocols, and technical reports.
* Ensure all processes meet quality standards including risk management.
Cross-Functional Collaboration:
* Partner with Prototyping, Quality, and Manufacturing teams to ensure seamless integration of new processes into production.
* Act as a technical liaison with suppliers to ensure material and component quality align with process requirements.
Leadership & Mentorship:
* Lead the optimization and rollout of a lean process development system within the company.
* Mentor junior engineers and technicians, fostering a collaborative and innovative team environment.
Qualifications:
* Bachelor's degree in engineering (e.g., Mechanical, Biomedical, or related field).
* 8+ years of experience in process development in the medical device industry.
* Demonstrated expertise in developing and scaling manufacturing processes for regulated environments.
The ideal candidate will possess strong analytical and problem-solving skills, excellent communication and project management skills, and a proven track record of delivering high-quality results in a fast-paced environment.