Senior NPI Engineer - Medical Devices Production & Launch

CroiValve; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

CroíValve seeks a Senior NPI Engineer to advance a cutting-edge structural heart device in its Dublin office. You will drive design development through verification, clinical trials, validation and regulatory approvals, coordinating cross‑functional teams and ensuring GMP compliance.

You will develop manufacturing processes, source tooling, manage timelines and budgets, and oversee documentation such as DHR/DMR and validation records to support product builds and regulatory submission.

Qualifications

• 5–10+ years of experience in medical devices.
• Strong ability to communicate and organize tasks.
• Proven experience developing manufacturing processes and documentation.

Responsibilities

• Coordinate day-to-day production management to meet build plan objectives.
• Develop manufacturing processes and provide training to technicians and operators.
• Source and implement tooling and instrumentation for device manufacture.
• Manage projects with cross-functional teams within budget and timelines.
• Develop and update manufacturing documentation and specs to regulatory standards.
• Execute process FMEAs, validations, and risk controls in manufacturing environments.

Skills

Project coordination

Process development

Cross-functional collaboration

Documentation skills

Regulatory awareness

Education

Mechanical engineering

Biomedical engineering

Job description

CroíValve seeks a Senior NPI Engineer to advance a cutting-edge structural heart device in its Dublin office. You will drive design development through verification, clinical trials, validation and regulatory approvals, coordinating cross‑functional teams and ensuring GMP compliance.

You will develop manufacturing processes, source tooling, manage timelines and budgets, and oversee documentation such as DHR/DMR and validation records to support product builds and regulatory submission.