Contract: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 ResponsibilitiesLead and support early-stage process development activities for next-generation medical device programmesDrive equipment development, selection, and qualification in partnership with vendors and internal stakeholdersConduct process characterisation studies to define, optimise, and document robust manufacturing processesApply structured problem-solving and root cause analysis (RCA) methodologies to resolve technical challengesManage vendor relationships and coordinate external equipment and material suppliersPrepare and review technical documentation including protocols, reports, and design history file (DHF) inputsCollaborate closely with cross-functional teams including design, operations, and quality functionsSupport design for manufacturability (DFM) reviews and contribute to technology transfer activitiesWork within a team of cross-development engineers, guided by senior development leadsRequired Skills & ExperienceMinimum5 years' relevant experiencein process development or manufacturing engineering within the medical device or life sciences industryDemonstrated experience inprocess characterisation— defining and validating robust manufacturing processesStrong background inequipment development, specification, and vendor managementProven 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 environmentsFluent English (written and spoken) is requiredFamiliarity withstatistical toolsand process capability analysis (Cp/Cpk, SPC, DOE)Background in NPI / technology transfer projectsSix Sigma or Lean certification (desirable but not essential — process experience outweighs certification)EducationMinimumLevel 7qualification in Engineering, Science, or a related disciplineLevel 8degree (Honours Bachelor's) or postgraduate qualification strongly preferredWhat's on Offer18-month contract with a realistic potential to extend (reviewed at 6 and 12 months)Collaborative, team-based environment working on genuinely innovative, next-generation productsCross-functional exposure across design, operations, and development functionsFlexible start/finish times to support work-life balanceOne day per week remote working flexibilityGalway city base – accessible location within the Parkmore business parkHow to ApplyIf you have the relevant experience and are excited by early-stage medical device development, we would love to hear from you.Operational Excellence Specialist – Lean Labs
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