Staff Process Development Engineer
This is a permanent role based in Galway. Our client is seeking an experienced Staff Process Development Engineer to join their team.
The ideal candidate will have experience working with Catheters, be available for a full-time onsite role, and have an existing work permit/ visa for Ireland (Stamp 4 or EU passport) residing within a commutable distance of Galway.
Job Summary:
* Design, develop, and optimize manufacturing processes for innovative medical devices, ensuring compliance with industry regulations.
* 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.
Key Responsibilities:
* Process and material benchmarking
* Evaluate and implement state-of-the-art technologies, materials, and methods to optimize manufacturing operations.
* Scale up processes from pilot-scale to full-scale production, ensuring robustness and repeatability.
* Direct teams internally and work 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 rollout 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:
* Honours 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).
* 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).
Benefits:
* Competitive salary and performance-based bonus.
* Laya Healthcare to include dependents from day 1.
* Occupational Pension Scheme.
* Additional Annual Leave Opportunities for professional growth and development.