Process Development Engineer
ICS Medical Devices - Ballybrit, County Galway
As part of our continued growth, ICS Medical Devices is seeking a Process Development Engineer to support the development, validation, and optimization of manufacturing processes for new and existing medical device products.
Role Overview
The Process Development Engineer will be responsible for developing robust, scalable, and compliant manufacturing processes. This role works cross-functionally to ensure processes meet performance, cost, and regulatory requirements.
This is an excellent opportunity for an engineer who thrives in a regulated, fast-paced medical device environment and is passionate about continuous improvement.
Key Responsibilities
- Lead development and optimization of manufacturing processes for new product introductions (NPI).
- Design and execute process validation activities (IQ/OQ/PQ) in compliance with FDA, ISO 13485, and MDR requirements.
- Develop and maintain process documentation including SOPs, work instructions, PFMEA, and control plans.
- Conduct process capability analysis and implement statistical methods (SPC, DOE).
- Identify and implement process improvements to enhance quality, yield, and efficiency.
- Collaborate with cross-functional teams to support product transfers and scale-up activities.
- Troubleshoot manufacturing issues and implement corrective/preventive actions.
- Support risk management activities in accordance with ISO 14971.
- Ensure compliance with GMP, Healty & Safety and internal quality management system.
Qualifications
Education
- Bachelor’s degree in engineering (e.g., Mechanical, Biomedical, or related field).
Experience
- 3+ years of experience in process development in the medical device industry.
- Demonstrated experience 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 cross-functional collaboration experience.
- Excellent 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).
Benefits
- Competitive salary and performance-based bonus
- Laya Healthcare cover upon commencement
- Occupational Pension Scheme upon commencement
- Additional Annual Leave
- Opportunities for professional growth and development.
Job Types: Full-time, Permanent
Benefits:
- Additional leave
- Bike to work scheme
- Company events
- Company pension
- Employee assistance program
- Employee discount
- On-site parking
- Private medical insurance
- Sick pay
Experience:
- Process Development: 2 years (required)
- Medical Devices: 2 years (required)
Work authorisation:
Work Location: In person
