Senior Design Engineer, R&D

Stryker Group; Carrigtwohill; On-site; EUR 65,000 - 90,000; Full time

Job summary

Stryker R&D Innovation Centre in Cork is seeking a Senior Mechanical Design Engineer to design, support, and improve the SafeAir Smoke Evacuation Pencil through post-market activities. You will refine requirements, evaluate design effectiveness, and implement cost- and manufacturability‑driven improvements across the lifecycle.

Working with Operations, Quality, Regulatory and suppliers, you will investigate field issues, support CAPA, and drive design and process improvements in a regulated

Qualifications

• Degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related discipline.
• Experience in medical device design or sustaining engineering.
• Knowledge of ISO 13485 / FDA regulatory practices.

Responsibilities

• Own sustainment of the SafeAir Pencil across the product lifecycle.
• Lead root-cause investigations and drive design improvements.
• Collaborate with Operations, QA/RA, and Supply Chain to resolve issues.
• Support design changes and validation activities as required.

Skills

Mechanical design

Medical device engineering

Regulated development

Root cause analysis

Cross-functional collaboration

Leadership & ownership

Education

Bachelor's degree in Mechanical or related engineering

Tools

CAD

FEA

Job description

Senior Mechanical Design Engineer

Location: Stryker R&D Innovation Centre, Cork

12 month Fixed Term Contract

Please 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

• Qualifications
  • 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 organized 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 safety