We are seeking an experienced Staff Process Development Engineer for our Galway based 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.
Process and material 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.
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.
Continuous Improvement
Drive continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality.
Apply Six Sigma, Lean Manufacturing, and other methodologies to optimize process performance.
Monitor and analyze production data to identify and address process variances.
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.
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.
Hands-on experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).
Skills
In-depth knowledge of medical device regulations and standards, including ISO 13485 and FDA cGMP.
Strong proficiency in data analysis tools and techniques (DOE, Minitab, etc.).
Expertise in manufacturing technologies such as injection moulding, laser processing, automation, or additive manufacturing.
Excellent project management skills with a proven ability to lead cross-functional teams.
Strong verbal and written communication skills, including technical documentation.
Preferred Certification in Lean Six Sigma (Green Belt, Black Belt) or equivalent.
Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA).
Familiarity with cleanroom operations and sterilization processes (e.g., EtO, gamma).