Senior NPI Engineer

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 is looking for a Senior NPI Engineer to support the product development of a cutting-edge structural heart device through design development, verification, clinical trials, validation and regulatory approvals. This role is based full time in our Dublin office.

Key Responsibilities and Duties

• Co-ordinate day to day production management to meet company build plan objectives.
• Develop manufacturing processes and provide training to technicians and process operators.
• Source and implement tooling, instruments and technologies, as required to implement the manufacture of the device.
• Manage projects to tight timelines with cross functional team alignment and budget management.
• Develop specifications, process development, training, production instructions, material specifications and procurement.
• Develop and update documentation relating to equipment or processes to manufacture the device in a controlled manner in line with Regulatory standards, e.g. specifications, BOM, DHR, DMR, validation documents, etc.
• Develop and execute DOEs to characterize impact of process parameters on manufacture.
• Apply appropriate risk controls and measurement methods to minimise risk throughout the manufacturing process.
• Execute process FMEAs, process validations, including installation qualification, test method validation, software validation, operational and process qualifications.
• Work with contract manufacturers to implement appropriate production / assembly processes and layouts for manufacture of subassemblies.
• Support quality related activities for device manufacturing, ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods, CAPA and NCR resolutions).
• Support product builds to ensure product is manufactured in line with specifications
• Plan daily activities of operators to achieve production to demand plan. This includes supervision and adjustment to daily / weekly production plans to remain on-track.
• Support identification and implementation of process improvements (yield, capacity, efficiencies).
• Develop a thorough "hands-on" understanding of manufacturing procedures, processes and equipment.
• Ensure that a high standard of compliance with GMP is maintained in the manufacturing areas.
• Support of EHS rules and requirements and drives identification and implementation of adequate control measures.

Education and Experience

• B.S. or Masters degree in mechanical engineering, biomedical engineering, or related disciplines
• 5-10+ years experience in medical devices
• Excellent communication, organizational and time management skills
• Considerable experience preparing technical documentation

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned from time to time.