Senior NPI Engineer

CroíValve; Dublin; On-site; EUR 80,000 - 120,000; Full time

Job summary

CroíValve is seeking a Senior NPI Engineer in Dublin to drive product development of a cutting-edge structural heart device through design, verification, clinical trials, validation and regulatory approvals. This full-time role sits in our Dublin office.

You will coordinate manufacturing processes, develop specs, manage cross-functional projects, and ensure GMP compliance while collaborating with contract manufacturers to bring subassemblies to production.

Qualifications

• BS or MS in mechanical engineering, biomedical engineering, or related disciplines.
• 5+ years experience in medical devices.
• Excellent communication, organizational and time management skills.
• Considerable experience preparing technical documentation.

Responsibilities

• 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 required to manufacture 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.
• Develop and execute DOEs to characterize impact of process parameters on manufacture.
• Apply risk controls and measurement methods to minimise risk throughout the manufacturing process.
• Execute process FMEAs, process validations including IQ, test method validation, software validation, OQ and PQ.
• Work with contract manufacturers to implement production/assembly processes and layouts for subassemblies.
• Support quality activities for device manufacturing including inspection standards, plans and CAPA/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 and adjust schedules.
• Support identification and implementation of process improvements (yield, capacity, efficiencies).
• Develop hands-on understanding of manufacturing procedures, processes and equipment.
• Ensure GMP compliance in manufacturing areas.
• Support EHS rules and drive adequate control measures.

Education

B.S. or Masters in mechanical engineering, biomedical engineering or related disciplines

5-10+ years experience in medical devices

Excellent communication, organizational and time management skills

Experience preparing technical documentation

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.