Senior Medical Device Systems Engineer Lead

Par Health; Dublin; On-site; EUR 90,000 - 140,000; Full time

Job summary

Keenova is seeking a Principal/Senior Systems Engineer to lead system definition and development for medical device projects. You will work with electrical, mechanical and software teams to design optimal system solutions and ensure lifecycle excellence.

Responsibilities include defining system inputs, maintaining regulatory alignment, and driving quality through design controls while mentoring junior staff and collaborating with stakeholders.

Qualifications

• 8+ years of Systems Engineering experience in complex electrical/ mechanical products.
• 5+ years in medical device development is preferred.
• Demonstrated familiarity with medical device standards (ISO 13485, ISO 14971, IEC 60601).
• INCOSE certification or knowledge of SE best practices is a plus.

Responsibilities

• Lead system definition and development activities across medical device projects.
• Create system-level design input requirements and subsystem requirements.
• Collaborate with electrical, mechanical and software teams to define optimal system solutions.
• Support regulatory and quality activities related to medical devices.
• Ensure design controls process compliance and contribute to product quality improvements.

Skills

Systems thinking

Cross-functional collaboration

Regulatory awareness

Leadership

Problem solving

Education

BS degree in engineering or science

Tools

Jama Connect

Job description

Keenova is seeking a Principal/Senior Systems Engineer to lead system definition and development for medical device projects. You will work with electrical, mechanical and software teams to design optimal system solutions and ensure lifecycle excellence.

Responsibilities include defining system inputs, maintaining regulatory alignment, and driving quality through design controls while mentoring junior staff and collaborating with stakeholders.