Sr. Process Engineer - Galway

Location:Galway, Ireland

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

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.

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• 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
  

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• Minimum5 years' relevant experiencein process development or manufacturing engineering within the medical device or life sciences industry
  
• Demonstrated experience inprocess characterisation— defining and validating robust manufacturing processes
  
• Strong background inequipment development, specification, and vendor management
  
• Proven ability inroot cause analysisand 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
  

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• Experience inballoon catheteror cardiovascular device manufacturing processes
  
• Familiarity withstatistical toolsand 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) xcfaprz
  
• Project management experience
  

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

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• 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
  

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