Senior Process Development Engineer – Medical Devices

About the role

We are seeking a hands‑on Senior Process Development Engineer to join a fast‑growing medical‑device company in Oranmore, Galway. The role combines design, validation and continuous‑improvement of manufacturing processes, supporting rapid scale‑up and ensuring regulatory compliance.

Key responsibilities

• Design, develop and validate robust manufacturing processes (IQ, OQ, PQ) for new and existing products.
• Scale production lines to meet aggressive year‑on‑year growth targets.
• Lead Lean initiatives such as Kaizen events, Value‑Stream Mapping and DMAIC projects to drive efficiency.
• Initiate and manage automation projects from concept through implementation.
• Resolve non‑conformances and provide day‑to‑day support on the shop floor.
• Write User Requirements Specifications, validation protocols and technical reports for senior leadership.

Required profile

• Level 8 engineering degree (or equivalent) with at least 5 years of experience in medical‑device or regulated manufacturing.
• Proven track record of delivering Lean manufacturing projects with measurable outcomes.
• Hands‑on experience writing URS and leading equipment and process validations.
• Strong knowledge of ISO 13485 and FDA regulations.
• Comfortable working both on the production floor and presenting to senior stakeholders.

Required skills

• Lean manufacturing methodologies (Kaizen, VSM, DMAIC)
• Process validation (IQ, OQ, PQ)
• Automation concept development and implementation
• User Requirements Specification (URS) authoring
• ISO 13485 compliance
• FDA regulatory requirements

What we offer

• Competitive salary up to €75,000 per year.
• Opportunity to shape the manufacturing function of a rapidly scaling company.
• Dynamic, hands‑on environment with direct impact on product delivery.