Sr. Process Engineer - Galway

CPL

  • Galway
  • €60,000-80,000 per year
  • Temporary
  • Full-time
  • 14 days ago
Senior Process Development EngineerLocation: Galway, IrelandContract: 18 Months (with potential for extension based on review)About the RoleAn 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 ApplyIf you have the relevant experience and are excited by early-stage medical device development, we would love to hear from you.

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