Lead Systems Engineer (Principal)

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

Our client is a leading global pharmaceutical and medical devices organisation with a strong track record in the development and delivery of complex healthcare technologies. They are seeking to appoint a Principal Systems Engineer to join their Device Engineering function, leading systems engineering activity across the development and lifecycle management of innovative medical devices.

The Role

Reporting to the Systems Engineering Manager, the Principal Systems Engineer will take a lead role in the definition and development of complex medical device systems. Working across multidisciplinary engineering teams, the successful candidate will translate user and stakeholder needs into robust system requirements and architectures, while providing technical leadership throughout the product development lifecycle.

Key responsibilities will include:

• Leading systems definition and development activities across medical device development and lifecycle management programmes.
• Translating user, customer and stakeholder needs into clear system-level design requirements.
• Developing and evaluating system architectures in collaboration with electrical, mechanical and software engineering teams.
• Decomposing system requirements into subsystem requirements, ensuring appropriate functional coverage and integration.
• Acting as a system owner and subject matter expert, providing technical leadership on system-level decisions.
• Applying structured systems engineering and problem-solving methodologies to complex technical challenges.
• Partnering with Verification, Validation, Quality, Clinical, Commercial and Regulatory Affairs teams to resolve system definition and development challenges.
• Supporting Quality and Regulatory activities and ensuring development is undertaken in accordance with applicable design controls and quality systems.
• Leading and facilitating key architectural and design decisions to support effective and timely project delivery.
• Identifying opportunities for product improvement and innovation while supporting the development and knowledge-sharing of others.

The Person

The successful candidate will be an accomplished Systems Engineer with significant experience in the development of complex electromechanical products within a regulated medical device environment. They will combine strong technical depth with the ability to lead, influence and bring together multidisciplinary teams.

• 8+ years' Systems Engineering experience within complex electrical and mechanical product development, ideally including experience in a systems lead capacity.
• 5+ years' experience within medical device development.
• Strong knowledge of medical device development standards and regulations, including ISO 13485, ISO 14971 and IEC 60601.
• A bachelor's degree or higher in Engineering, Science or a related discipline.
• Strong understanding of systems engineering principles, requirements management, system architecture and multidisciplinary product development.
• Excellent communication and stakeholder management skills, with the ability to influence both technical and non-technical audiences.
• Demonstrated ability to lead cross-functional technical discussions, build consensus and drive effective decision-making.
• A proactive and solutions-focused approach, with strong problem-solving and continuous improvement capability.
• INCOSE certification or demonstrated knowledge of Systems Engineering best practice would be advantageous.
• Experience with Systems Engineering tools such as Jama Connect would also be beneficial.

The Package

• Performance-related bonus
• Pension
• Hybrid working with occasional travel