Senior Mechanical Design Engineer – Medical Devices (R&D)

Stryker; Carrigtwohill; On-site; EUR 47,000 - 77,000; Full time

Job summary

Stryker R&D Innovation Centre, Cork, is seeking a Senior Mechanical Design Engineer to own the sustainment of the SafeAir Smoke Evacuation Pencil and drive design improvements across the product lifecycle.

You will collaborate with Operations, Quality, Regulatory and suppliers to investigate field issues, support CAPA and risk management, and ensure compliance with ISO 13485 / FDA in a regulated medical device environment. This is a 12 month fixed-term contract with on-site duties in Cork.

Qualifications

• Degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related discipline.
• Strong experience in medical device engineering (design and/or sustaining).
• Knowledge of design control, change management, and regulated product development (ISO 13485 / FDA).
• Experience with validation/verification approaches and statistical analysis.

Responsibilities

• 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)
• 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
• 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
• 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
• Partner closely with manufacturing and suppliers to resolve technical design issues and improve process capability
• Support supplier qualification, transfer activities, and PPAP where required
• Define and execute verification and validation strategies to support product changes
• Make informed engineering decisions balancing technical, quality, regulatory, and commercial considerations
• Provide technical leadership within cross-functional teams, influencing decisions and driving alignment
• Contribute to engineering best practices within the team

Skills

Mechanical design

Medical device engineering

Problem solving

Root cause analysis

CAD

Cross-functional collaboration

Regulatory knowledge

Design for manufacturability

Leadership

Stakeholder management

Education

Bachelor's degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related discipline

Tools

CAD tools

FEA

Job description

Stryker R&D Innovation Centre, Cork, is seeking a Senior Mechanical Design Engineer to own the sustainment of the SafeAir Smoke Evacuation Pencil and drive design improvements across the product lifecycle.

You will collaborate with Operations, Quality, Regulatory and suppliers to investigate field issues, support CAPA and risk management, and ensure compliance with ISO 13485 / FDA in a regulated medical device environment. This is a 12 month fixed-term contract with on-site duties in Cork.