Staff Process Development Engineer
We are seeking an experienced Staff Process Development Engineer for our client. This critical role will focus on designing, developing, and optimizing manufacturing processes for innovative medical devices, ensuring compliance with industry regulations.
The Role:
Process Development: Further development of a standard approach to process development.
* Benchmarking: Evaluate and implement state-of-the-art technologies, materials, and methods to optimize manufacturing operations.
Achieved through:
Benchmarking Research Network development vendor and education centres.
Scale up processes from pilot-scale to full-scale production, ensuring robustness and repeatability.
* Directing teams internally and working with customers through the process.
* Lead the development and validation of new manufacturing processes from concept to production.
Key Responsibilities:
* 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 optimisation and roll out of a lean process development system within the company.
Lead technical projects, including resource planning, timeline management, and risk assessment.
Mentor junior engineers and technicians, fostering a collaborative and innovative team environment.
Provide subject-matter expertise during audits and technical reviews.
Requirements:
* Bachelors 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.
* Hands-on experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).
About Us:
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo, and Dublin.