Senior Process Development Engineer

Location: Galway, Ireland

Contract: 18 Months (with potential for extension based on review)

About the Role

An exciting opportunity has arisen for a Senior Process Development Engineer to join a world-leading medical device organisation based in Galway. This is a hands-on, early-stage new product development role supporting next-generation medical device programmes at a globally recognised site.

You will be embedded within a collaborative, cross-functional engineering team working on innovative device development. The successful candidate will play a key role in shaping and driving process development activities from early feasibility through to manufacturing readiness.

Key Responsibilities

• Lead and support early-stage process development activities for next-generation medical device programmes
• Drive equipment development, selection, and qualification in partnership with vendors and internal stakeholders
• Conduct process characterisation studies to define, optimise, and document robust manufacturing processes
• Apply structured problem-solving and root cause analysis (RCA) methodologies to resolve technical challenges
• Manage vendor relationships and coordinate external equipment and material suppliers
• Prepare and review technical documentation including protocols, reports, and design history file (DHF) inputs
• Collaborate closely with cross-functional teams including design, operations, and quality functions
• Support design for manufacturability (DFM) reviews and contribute to technology transfer activities
• Work within a team of cross-development engineers, guided by senior development leads

Required Skills & Experience

• Minimum 5 years' relevant experience in process development or manufacturing engineering within the medical device or life sciences industry
• Demonstrated experience in process characterisation — defining and validating robust manufacturing processes
• Strong background in equipment development, specification, and vendor management
• Proven ability in root cause analysis and structured problem solving (e.g. 8D, Fishbone, 5 Why)
• Experience preparing technical documentation in a regulated environment (ISO 13485, FDA QSR)
• Strong interpersonal and communication skills; comfortable working in cross-functional team environments
• Fluent English (written and spoken) is required

Desirable Skills & Experience

• Experience in balloon catheter or cardiovascular device manufacturing processes
• Familiarity with statistical tools and process capability analysis (Cp/Cpk, SPC, DOE)
• Background in NPI / technology transfer projects
• Six Sigma or Lean certification (desirable but not essential — process experience outweighs certification)
• Project management experience

Education

• Minimum Level 7 qualification in Engineering, Science, or a related discipline
• Level 8 degree (Honours Bachelor's) or postgraduate qualification strongly preferred

What's on Offer

• 18-month contract with a realistic potential to extend (reviewed at 6 and 12 months)
• Collaborative, team-based environment working on genuinely innovative, next-generation products
• Cross-functional exposure across design, operations, and development functions
• Flexible start/finish times to support work-life balance
• One day per week remote working flexibility
• Galway city base – accessible location within the Parkmore business park

How to Apply

If you have the relevant experience and are excited by early-stage medical device development, we would love to hear from you.