NPI Quality Engineer II — Lead New Product Quality

Integer Holdings Corporation; Spiddal; On-site; EUR 60,000 - 90,000; Full time

Job summary

Integer Holdings Corporation is seeking an NPI Engineer to support new product introductions in the medical device sector. You will apply advanced quality tools under guidance from senior engineers to resolve design and process issues and ensure customer and regulatory requirements are met.

You will contribute to root cause analysis, develop test methods, and validate processes while maintaining QMS compliance and collaboration across a cross-functional team.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 3 years of relevant experience in NPI/medical devices or related quality engineering.
• Experience with quality tools and regulatory environments (QMS, FDA) preferred.

Responsibilities

• Support regulatory inspections, audits, and inquiries related to product design and manufacturing quality.
• Develop test methods and improve existing methods including tooling, fixtures, and templates.
• Perform testing and validation of new test methods with data analysis (gage R&R, statistics).
• Update SOPs and procedures related to test method development and product/process validation.
• Provide input for root cause analysis and investigations within KPI-driven timelines.
• Participate in cross-functional reviews and ensure PDP alignment and compliance across the product development process.

Skills

Root cause analysis

Statistical analysis

Problem solving

Regulatory compliance

Education

Bachelor’s degree in engineering or related field

Tools

Minitab

Microsoft Office

Job description

Integer Holdings Corporation is seeking an NPI Engineer to support new product introductions in the medical device sector. You will apply advanced quality tools under guidance from senior engineers to resolve design and process issues and ensure customer and regulatory requirements are met.

You will contribute to root cause analysis, develop test methods, and validate processes while maintaining QMS compliance and collaboration across a cross-functional team.