Senior Mechanical Design Engineer – Medical Devices

About the role

The Senior Mechanical Design Engineer will own the technical sustainment of the SafeAir Smoke Evacuation Pencil, ensuring performance, reliability and regulatory compliance throughout its lifecycle. Working within Stryker’s R&D Innovation Centre in Cork, you will collaborate with Operations, Quality, Regulatory and suppliers to resolve field issues, drive CAPA activities and implement design improvements.

Key responsibilities

• Own technical sustainment of the SafeAir Smoke Evacuation Pencil across its lifecycle.
• Act as primary engineering contact for cross‑functional teams (Operations, QA/RA, Supply Chain).
• Lead root‑cause investigations for customer complaints, field issues and manufacturing challenges.
• Drive NC/CAPA activities and ensure timely closure and risk mitigation.
• Define and execute verification and validation strategies for product changes.
• Lead engineering change requests (ECRs) and supplier changes in compliance with design control.
• Partner with manufacturing and suppliers to resolve technical design issues and support PPAP activities.

Required profile

• Degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related discipline.
• Minimum 2 years experience in medical device engineering, preferably with electro‑mechanical products.
• Strong knowledge of design control, change management and regulated product development (ISO 13485, FDA).
• Proven ability to lead technical workstreams independently with minimal supervision.
• Excellent stakeholder management and communication skills.

Required skills

• Proficiency in CAD and engineering analysis tools (tolerance analysis, Finite Element Analysis).
• Experience with validation/verification methods and statistical analysis.
• Strong problem‑solving and root‑cause analysis using structured, data‑driven methodologies.
• Knowledge of materials, manufacturing processes and design for manufacturability.