Principal Systems Engineer - Medical Devices (Hybrid)

HRM Search Partners; Dublin; Hybrid; EUR 110,000 - 160,000; Full time

Benefits offered by this job

Performance-related bonus

Pension

Hybrid working with occasional travel

Job summary

HRM Search Partners is recruiting a Principal Systems Engineer for a leading global pharmaceutical and medical devices organisation in Ireland. You will lead systems engineering across development and lifecycle management of electromechanical medical devices, translating needs into robust system requirements.

The role requires 8+ years in systems engineering in regulated environments, 5+ years in medical device development, and knowledge of ISO 13485, ISO 14971 and IEC 60601.

Qualifications

• 8+ years' Systems Engineering experience within complex electrical and mechanical product development.
• 5+ years' experience within medical device development.
• Strong knowledge of medical device development standards and regulations (ISO 13485, ISO 14971, IEC 60601).

Responsibilities

• Lead systems definition and development activities across medical device development and lifecycle management programmes.
• Translate user, customer and stakeholder needs into clear system-level design requirements.
• Develop and evaluate system architectures with multi-disciplinary teams.
• Decompose system requirements into subsystem requirements and ensure integration.
• Act as system owner and provide technical leadership on system-level decisions.
• Apply structured systems engineering methodologies to complex challenges.
• Collaborate with Verification, Validation, Quality, Clinical, Regulatory Affairs to resolve issues.
• Support Quality and Regulatory activities and ensure design controls are followed.
• Lead architectural/design decisions to support timely delivery.
• Identify opportunities for product improvement and knowledge-sharing.

Skills

Systems Engineering

Electrical & Mechanical

Medical device development

Regulatory standards

Requirements management

Systems architecture

Leadership

Communication

Education

Engineering degree

Tools

Jama Connect

Job description

HRM Search Partners is recruiting a Principal Systems Engineer for a leading global pharmaceutical and medical devices organisation in Ireland. You will lead systems engineering across development and lifecycle management of electromechanical medical devices, translating needs into robust system requirements.

The role requires 8+ years in systems engineering in regulated environments, 5+ years in medical device development, and knowledge of ISO 13485, ISO 14971 and IEC 60601.