Principal Systems Engineer – Medical Devices Leader

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

Job summary

Keenova in Dublin seeks a Principal/Senior Systems Engineer to lead system definition and development across medical device projects. You will own system architecture, requirements decomposition, and cross-functional collaboration with electrical, mechanical, and software teams.

You have 8+ years in systems engineering, 5+ in medical devices, and familiarity with ISO 13485/14971 and IEC 60601. INCOSE certification is a plus; Jama Connect experience is preferred.

Qualifications

• BS degree (or above) in a scientific or engineering discipline.
• 8+ years' Systems Engineering experience in complex Electrical/Mechanical products.
• 5+ years' medical device development experience.
• Demonstrated development experience using key medical device standards (ISO 13485, ISO 14971, IEC 60601).
• INCOSE certification and/or demonstrated knowledge of Systems Engineering best-practices is a distinct advantage.
• Familiarity with Systems Engineering tools (Jama Connect) preferable.
• Facilitation and presentation skills: Strong ability to engage and influence diverse stakeholder groups.
• Communication and interpersonal skills: Excellent verbal and written communication across cross-functional teams and senior leadership.
• Organisation and time management: Strong ability to manage multiple priorities and deadlines.
• GDP compliance and documentation standards focus.
• Operational agility: Comfortable in fast-paced environments.
• Problem-solving and continuous improvement.
• Adaptability and initiative; ownership of tasks.
• Collaboration and knowledge sharing: Mentors others and seeks feedback from cross-discipline teams.

Responsibilities

• Defines system requirements and guides lifecycle activities with cross-functional teams.
• Leads system definition and architecture discussions across electrical, mechanical and software domains.
• Decomposes system requirements into subsystems including software with testable coverage.
• Assesses technical challenges and uses data-driven methods to resolve issues.
• Acts as system owner/SME for project decisions and regulatory support.
• Supports Regulatory and Quality activities related to medical devices; ensures design controls compliance.
• Leads project schedules with program managers and escalates issues timely.
• Interacts with Verification, Validation, Quality, Commercial, Clinical and Regulatory teams to resolve challenges.
• Identifies product improvements and opportunities for innovation.

Skills

Systems thinking

Cross-functional Collaboration

Regulatory & compliance awareness

Communication skills

Problem solving

Education

BS degree in engineering or related field

INCOSE certification

Tools

Jama Connect

Job description

Keenova in Dublin seeks a Principal/Senior Systems Engineer to lead system definition and development across medical device projects. You will own system architecture, requirements decomposition, and cross-functional collaboration with electrical, mechanical, and software teams.

You have 8+ years in systems engineering, 5+ in medical devices, and familiarity with ISO 13485/14971 and IEC 60601. INCOSE certification is a plus; Jama Connect experience is preferred.