Process Development Engineer

2 weeks ago

Cork City, Ireland Morgan McKinley Full time

This role partners closely with R&D Engineering and Manufacturing teams to design and implement reliable, high-performance manufacturing processes for medical device production. The position involves managing multiple projects related to large-scale automation equipment for device assembly and testing, taking processes and equipment from concept through to full implementation.

Key Responsibilities

- Develop high-yield, high-capability manufacturing processes.
- Optimize equipment and process performance to ensure efficient, repeatable transfer to manufacturing.
- Collaborate with R&D engineering to support new medical device design and transition validated products into production.
- Engage with vendors on equipment design and builds, providing support from early concept through on-site deployment.
- Design and enhance equipment and processes to support New Product Introductions (NPIs).
- Prepare, maintain, and update technical and manufacturing documentation.
- Author and execute validation and qualification protocols.
- Drive continuous quality and process improvements.
- Partner with cross-functional teams on current and future process development initiatives.
- Build and maintain specialist expertise within the Cork site.
- Lead commissioning of new microcatheter manufacturing technologies, including production ramp-up, validations, and continuous improvement initiatives.
- Identify and assess opportunities for advancing medical device technology.
- Collaborate with EHS to evaluate new equipment, processes, and materials for environmental impact, ensuring risks are minimized.

Qualifications & Experience

- Bachelor's degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, etc.).
- Minimum of 3 years' experience in the medical device industry.
- Strong interpersonal, communication, and leadership skills.
- Proven analytical and problem-solving abilities.
- Hands-on experience in at least one of the following areas:
- Design of Experiments (DOE)
- Process development and characterization
- Process troubleshooting and problem solving
- Process validation
- DMAIC methodology
- Equipment validation
- New product introduction (NPI)

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