NPI Quality Engineer II: Drive Medical Device Quality

Integer Holdings Corporation; Galway; On-site; EUR 50,000 - 70,000; Full time

Job summary

Integer Holdings Corporation in Galway, Ireland seeks an NPI Engineer to advance new product introduction in the medical device sector. You will apply advanced quality tools to resolve problems and ensure design and manufacturing quality meet stringent standards.

You will work under guidance from senior engineers to support test method development, process validation, and cross-functional reviews, driving continuous improvement and compliance with QMS, FDA/regulatory requirements, and PDP

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum 3 years relevant experience in device/NPI environments.
• Awareness of ISO, QSR, UL, MDD, TGA and related regulatory standards.

Responsibilities

• Lead generation and completion of protocols and reports for test method validations.
• Support regulatory inspections, audits, investigations, and inquiries.
• Contribute to PDP alignment, design verification/validation, and risk management per ISO14971.
• Perform root cause investigations and CAPA activities with data analysis.

Skills

NPI

Minitab

Root cause analysis

Statistical analysis

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office

Job description

Integer Holdings Corporation in Galway, Ireland seeks an NPI Engineer to advance new product introduction in the medical device sector. You will apply advanced quality tools to resolve problems and ensure design and manufacturing quality meet stringent standards.

You will work under guidance from senior engineers to support test method development, process validation, and cross-functional reviews, driving continuous improvement and compliance with QMS, FDA/regulatory requirements, and PDP