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
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 *****, 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 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)
Project management experience
Education
MinimumLevel 7qualification in Engineering, Science, or a related discipline
Level 8degree (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.
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