Work Flexibility: Hybrid or OnsiteSenior Mechanical Design EngineerLocation: Stryker R&D Innovation Centre, Cork12 month Fixed Term ContractPlease note this role does not meet the criteria to allow Stryker to sponsor a work permit.Role Summary:Design, support, and improve the SafeAir Smoke Evacuation Pencil through post‑market engineering activities, ensuring ongoing performance, compliance, and reliability. You will define and refine product requirements, evaluate design effectiveness, and implement improvements to enhance usability, safety, cost, and manufacturability across the product lifecycle. This includes supporting product specifications, bills of materials, and validation activities to ensure fitness‑for‑use.Working closely with Operations, Quality, Regulatory, and suppliers, you will apply engineering judgement to investigate field issues, support CAPA activities, and drive design and process improvements. This is an individual contributor role requiring independent problem solving, attention to detail, and the ability to manage multiple priorities in a regulated medical device environment.This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.Key ResponsibilitiesProduct Ownership & SustainmentOwn technical sustainment of the SafeAir Smoke Evacuation Pencil, ensuring performance, reliability, and compliance across the product lifecycleAct as the primary engineering point of contact for cross-functional teams (Operations, QA/RA, Supply Chain)Complex Problem Solving & InvestigationsLead root cause investigations for customer complaints, field issues, and manufacturing challengesApply structured problem-solving methodologies and data analysis to drive robust, long-term solutionsNC/CAPA & Risk ManagementLead and deliver NC/CAPA activities, ensuring timely closure and effective risk mitigationAssess product risks and implement design or process improvements to enhance safety and reliabilityDesign & Change LeadershipDrive design improvements to optimise usability, manufacturability, and costLead engineering changes (ECRs), including supplier changes product enhancements, ensuring alignment with design control requirements.Support process updates from a design perspectiveManufacturing & Supplier InterfacePartner closely with manufacturing and suppliers to resolve technical design issues and improve process capabilitySupport supplier qualification, transfer activities, and PPAP where requiredValidation & Technical Decision MakingDefine and execute verification and validation strategies to support product changesMake informed engineering decisions balancing technical, quality, regulatory, and commercial considerationsTechnical Leadership & InfluenceProvide technical leadership within cross-functional teams, influencing decisions and driving alignmentContribute to engineering best practices within the teamQualifications, Knowledge & SkillsDegree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related disciplineStrong experience in medical device engineering (design and/or sustaining), ideally in electro-mechanical productsTechnical CapabilityDeep understanding of design control, change management, and regulated product development (ISO 13485 / FDA)Strong problem-solving and root cause analysis capability (e.g. structured methodologies, data-driven decisions)Experience with validation/verification approaches and statistical analysisDesign & Engineering ToolsProficient in CAD and engineering analysis tools (e.g. tolerance analysis, FEA – as applicable)Strong understanding of materials, manufacturing processes, and design for manufacturabilityLeadership & OwnershipDemonstrated ability to lead technical workstreams independently with minimal supervisionProven ability to manage ambiguity and drive issues to resolution across functionsCollaboration & CommunicationStrong stakeholder management skills, with the ability to influence across functions and levelsClear communicator, capable of presenting technical information and driving decisionsExecution & MindsetHighly organised with the ability to manage multiple priorities effectivelyDetail-oriented, with strong judgement based on analysis of technical dataContinuous improvement mindset with focus on product performance and patient safetyTravel Percentage: 10%