Senior Medical Device Systems Engineer

Mallinckrodt Pharmaceuticals; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Keenova in College Park, Dublin - Ireland is seeking a Principal/Senior Systems Engineer to lead system definition and development activities in medical device projects and to contribute to other programs.

You will align system engineering activities with user needs, guide lifecycle management, ensure compliance with design controls and GDP documentation, and collaborate with regulatory, quality, clinical, and engineering teams to deliver safe and effective devices.

Qualifications

• BS degree in engineering or science required.
• 8+ years of systems engineering experience in complex electrical/mechanical products.
• Experience with medical device standards (ISO 13485, ISO 14971, IEC 60601) and regulatory processes.

Responsibilities

• Defines system requirements and architecture with cross-functional teams.
• Leads lifecycle activities across medical device development projects.
• Owns system-level decisions and contributes to regulatory and quality activities.
• Ensures design controls, risk management, and GDP documentation are maintained.

Skills

Systems Engineering

Leadership

Cross-functional collaboration

Communication

Education

BS degree in engineering or scientific discipline

Tools

Jama Connect

Job description

Keenova in College Park, Dublin - Ireland is seeking a Principal/Senior Systems Engineer to lead system definition and development activities in medical device projects and to contribute to other programs.

You will align system engineering activities with user needs, guide lifecycle management, ensure compliance with design controls and GDP documentation, and collaborate with regulatory, quality, clinical, and engineering teams to deliver safe and effective devices.