Senior Design Engineer, R&D

About the role

The Senior Design Engineer will own the technical sustainment of the SafeAir Smoke Evacuation Pencil, ensuring its performance, reliability and regulatory compliance throughout its lifecycle. You will work closely with Operations, Quality, Regulatory and supplier teams to resolve field issues, drive design improvements and support validation activities in a regulated medical‑device environment.

Key responsibilities

• Maintain technical sustainment of the SafeAir Pencil, acting as the primary engineering contact for cross‑functional teams.
• Lead root‑cause investigations for customer complaints, field issues and manufacturing challenges, applying structured problem‑solving methods.
• Drive NC/CAPA activities, assess product risks and implement design or process improvements.
• Lead engineering change requests (ECRs) and supplier changes, ensuring alignment with design‑control requirements.
• Partner with manufacturing and suppliers to resolve technical design issues and support qualification, transfer and PPAP activities.
• Define and execute verification and validation strategies for product changes.

Required profile

• Degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering or related discipline.
• Minimum 2 years experience in medical‑device engineering (design and/or sustaining), preferably with electro‑mechanical products.
• Strong understanding of design control, change management and regulated product development (ISO 13485, FDA).

Required skills

• Proficiency with CAD and engineering analysis tools (tolerance analysis, FEA).
• Experience in validation/verification, statistical analysis and root‑cause analysis.
• Knowledge of NC/CAPA processes, risk management and design for manufacturability.
• Familiarity with materials, manufacturing processes and electro‑mechanical product design.