Senior Design Engineer, R&D

Stryker Corporation; Cork; On-site; Confidential; Full time

Job summary

Stryker Corporation in Cork, Ireland, is hiring a Senior Mechanical Design Engineer for the R&D Innovation Centre. This hybrid/on-site role focuses on sustaining and improving the SafeAir Smoke Evacuation Pencil, featuring cross-functional collaboration, problem solving, and design control within a regulated medical device environment.

The job requires a degree in mechanical/related engineering and experience in electro-mechanical medical devices, with the ability to drive CAPA, NC activities,

Qualifications

• Degree in Mechanical, Biomedical, Manufacturing or related engineering field.
• Experience in medical device engineering (design/sustainment) preferred.
• Familiarity with ISO 13485 and FDA guidelines is desirable.

Responsibilities

• Own technical sustainment of the SafeAir Smoke Evacuation Pencil across lifecycle.
• Lead root cause investigations for field issues and manufacturing challenges.
• Drive NC/CAPA activities and risk mitigation.
• Lead engineering changes (ECRs) with supplier changes and product enhancements.
• Collaborate with Operations, QA/RA, and Supply Chain to resolve design issues.

Skills

Problem solving

Root cause analysis

Cross-functional collaboration

Attention to detail

Independent work

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

CAD

FEA

Design control

Job description

## Senior Design Engineer, R&DApplylocations: Carrigtwohill, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R568186Work Flexibility: Hybrid or Onsite**Senior Mechanical Design Engineer**Location: 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 Responsibilities*** **Product Ownership & Sustainment** + Own technical sustainment of the SafeAir Smoke Evacuation Pencil, ensuring performance, reliability, and compliance across the product lifecycle + Act as the primary engineering point of contact for cross-functional teams (Operations, QA/RA, Supply Chain)* **Complex Problem Solving & Investigations** + Lead root cause investigations for customer complaints, field issues, and manufacturing challenges + Apply structured problem-solving methodologies and data analysis to drive robust, long-term solutions* **NC/CAPA & Risk Management** + Lead and deliver NC/CAPA activities, ensuring timely closure and effective risk mitigation + Assess product risks and implement design or process improvements to enhance safety and reliability* **Design & Change Leadership** + Drive design improvements to optimise usability, manufacturability, and cost + Lead engineering changes (ECRs), including supplier changes product enhancements, ensuring alignment with design control requirements. + Support process updates from a design perspective* **Manufacturing & Supplier Interface** + Partner closely with manufacturing and suppliers to resolve technical design issues and improve process capability + Support supplier qualification, transfer activities, and PPAP where required* **Validation & Technical Decision Making** + Define and execute verification and validation strategies to support product changes + Make informed engineering decisions balancing technical, quality, regulatory, and commercial considerations* **Technical Leadership & Influence** + Provide technical leadership within cross-functional teams, influencing decisions and driving alignment + Contribute to engineering best practices within the team**Qualifications, Knowledge & Skills*** + Degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related discipline + Strong experience in medical device engineering (design and/or sustaining), ideally in electro-mechanical products* **Technical Capability** + Deep 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 analysis* **Design & Engineering Tools** + Proficient in CAD and engineering analysis tools (e.g. tolerance analysis, FEA – as applicable) + Strong understanding of materials, manufacturing processes, and design for manufacturability* **Leadership & Ownership** + Demonstrated ability to lead technical workstreams independently with minimal supervision + Proven ability to manage ambiguity and drive issues to resolution across functions* **Collaboration & Communication** + Strong stakeholder management skills, with the ability to influence across functions and levels + Clear communicator, capable of presenting technical information and driving decisions* **Execution & Mindset** + Highly organised with the ability to manage multiple priorities effectively + Detail-oriented, with strong judgement based on analysis of technical data + Continuous improvement mindset with focus on product performance and patient safetyTravel Percentage: 10%