We are seeking an experienced Senior Process Development Engineer to join our team.
This critical role will focus on designing, developing, and optimizing manufacturing processes for innovative medical devices, ensuring compliance with industry regulations
The ideal candidate will drive process improvements, lead technical projects, and act as a mentor to junior team members, contributing to the delivery of repeatable manufacturing process and in turn products at the highest quality and efficiency standards.
Responsibilities:
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 / support the optimisation and roll out of a lean process development system within ICS Medical.
- 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).
- 5+ 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
- Strong technical background and capabilities.
- Working knowledge of six sigma and/or lean engineering principles with a proven track record in use and delivery of results.
- 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.).
- Experience in manufacturing technologies such as injection moulding, laser processing, automation, or additive manufacturing.
- Strong project management skills with a proven ability to lead cross-functional teams.
- Excellent verbal and written communication skills, including technical documentation.
- 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 dependants from day 1.
- Occupational Pension Scheme.
- Additional Annual Leave
- Opportunities for professional growth and development.
Job Types: Full-time, Permanent
Additional pay:
- Bonus pay
Benefits:
- Additional leave
- Bike to work scheme
- Company events
- Company pension
- Employee assistance program
- Employee discount
- On-site parking
- Private medical insurance
- Sick pay
Schedule:
- Day shift
- Monday to Friday
Experience:
- Process Development: 5 years (required)
- Medical Devices: 3 years (required)
Work authorisation:
- Ireland (required)
Work Location: In person
Reference ID: Snr Process Dev Eng_2025
