NPI Quality Engineer II - Validate & Improve Medical Devices

integer; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Integer is seeking an NPI Engineer to drive New Product Introduction initiatives in the medical device space. You will apply advanced quality tools and engineering concepts, resolving design and process issues with guidance from senior engineers and managers.

You will support regulatory inspections, develop new test methods, perform gage R&R and data analysis using Minitab, and ensure all PDP steps meet ISO14971 and FDA requirements.

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum 3 years' relevant experience in a medical device context.
• Knowledge of FDA, QMS, ISO and regulatory requirements.

Responsibilities

• Lead and support NPI projects from design to production launch.
• Develop test methods, validate processes and generate protocols.
• Perform data analysis and contribute to root cause investigations.
• Collaborate with cross functional teams to ensure PDP compliance.
• Support regulatory inspections and internal quality activities.
• Communicate status and risks with engineering leadership.

Skills

NPI engineering

Quality systems

Statistical analysis

Team collaboration

Education

Bachelor's degree in engineering

Tools

Minitab

Microsoft Office

Job description

Integer is seeking an NPI Engineer to drive New Product Introduction initiatives in the medical device space. You will apply advanced quality tools and engineering concepts, resolving design and process issues with guidance from senior engineers and managers.

You will support regulatory inspections, develop new test methods, perform gage R&R and data analysis using Minitab, and ensure all PDP steps meet ISO14971 and FDA requirements.