Senior NPI Engineer

Mason Alexander; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Mason Alexander is assisting a growing medical device company based in Dublin to hire a Senior New Product Introduction (NPI) Engineer. The role leads production oversight and develops manufacturing processes for an implantable device.

You will support a team of operators, troubleshoot on the line, and drive DoE, FMEA, and process validation initiatives. This hands-on role is ideal for an experienced engineer passionate about designing components, fixtures and implementing new processes on the

Qualifications

• Minimum 5 years of engineering experience in medical device NPI, manufacturing, R&D or related.
• Experience in designing and validating manufacturing processes.
• Proficient with DoE, root cause analysis and problem solving.

Responsibilities

• Design and develop manufacturing processes including FMEAs, equipment qualifications, process validations, test methods.
• Oversee production on a daily basis and provide training to operators.
• Source and implement tooling, instruments and technologies into the manufacturing line.
• Develop process and materials specifications and associated documentation.
• Design and execute DoEs for manufacturing processes.
• Collaborate with suppliers and contract manufacturers.

Skills

DoE

Root cause analysis

Problem solving

Solidworks

Education

Bachelor's or Master's in Mechanical Engineering, Biomedical or related

Tools

Solidworks

Job description

A growing medical device company with a facility based in Dublin are seeking an experienced medical device development engineer to join their team. This is a permanent role.

As the Senior New Product Introduction (NPI) Engineer you will lead the production oversight and develop the manufacturing processes for an implantable device. You will support a team of operators & product builders to meet production objectives and troubleshoot on the line.

This is a hands‑on engineering role and is ideal for an experienced engineer who is passionate about designing & building components & fixtures and implementing new processes into a manufacturing line.

Responsibilities:

• Design & develop manufacturing processes including FMEAs, equipment qualifications, process validations, test methods.
• Oversee production on a daily basis including support & training to operators.
• Source, design and implement tooling, instruments and technologies into the manufacturing process.
• Develop process & materials specifications and associated documentation.
• Design & execute DoEs for manufacturing processes.
• Work with suppliers and contract manufacturers related to manufacturing processes and materials.
• Continuous improvement activities.

Requirements:

• Bachelors or Masters in engineering such as mechanical, biomedical or related.
• A minimum of 5 years experience as an engineer in the medical device industry within NPI, manufacturing, R&D, process engineering or related.
• Use of Solidworks
• DoE, root cause analysis and problem solving skills
• Process validation experience is an advantage