Senior NPI Quality Engineer: Process & Validation

integer; New Ross; On-site; EUR 70,000 - 110,000; Full time

Job summary

Integer is seeking an engineer to lead New Product Introduction projects, applying advanced engineering principles to design, validate, and transfer new products. You will develop test methods, perform gage R&R and statistical analyses, and document procedures with cross-functional teams.

Responsibilities include supporting regulatory inspections, CAPA, and process improvements while ensuring QMS and safety compliance.

Qualifications

• Bachelor’s degree in engineering or related field; master’s beneficial.
• 5+ years of progressive engineering experience in a technical role.
• Strong statistics knowledge and experience with Minitab.
• Exposure to ISO/Regulatory standards and PDP processes.

Responsibilities

• Lead NPI projects applying engineering principles to product design and process validation.
• Develop and document test methods, inspections, and process controls.
• Support regulatory inspections, audits, and CAPA activities.
• Collaborate with cross-functional teams to drive continuous improvement and 5 Sigma goals.
• Ensure adherence to QMS, safety, and quality requirements across PDP stages.

Skills

Problem solving

Written and oral communication

Team collaboration

Statistical analysis

Education

Bachelor's degree in engineering or related field

Master’s degree in engineering (benefit)

Tools

Minitab

Microsoft Office

Job description

Integer is seeking an engineer to lead New Product Introduction projects, applying advanced engineering principles to design, validate, and transfer new products. You will develop test methods, perform gage R&R and statistical analyses, and document procedures with cross-functional teams.

Responsibilities include supporting regulatory inspections, CAPA, and process improvements while ensuring QMS and safety compliance.