NPI Quality Engineer III - Lead New Product Validation

Integer Holdings Corporation; Brooklyn Park (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Integer Holdings Corporation seeks an engineer to lead New Product Introduction (NPI) initiatives, applying advanced engineering principles to deliver high-quality products. The role emphasizes QA, regulatory compliance, and cross-functional teamwork across design, manufacturing, and quality teams.

You will develop test methods, perform validation, and participate in risk management per PDP and ISO14971, driving continuous improvement and product transfers in a fast-paced environment.

Qualifications

• Bachelor’s degree in engineering or related field.
• Familiarity with Quality Management Systems (QMS) and FDA regulations.
• Strong problem-solving skills and collaboration in cross-functional teams.

Responsibilities

• Apply engineering principles to New Product Introduction (NPI) projects.
• Identify and evaluate procedures to ensure quality product.
• Develop new test methods including tooling, fixtures, and templates.
• Carry out testing and validation, including gage R&R and data analysis.
• Lead cross-functional NPI team reviews and provide technical input.
• Ensure compliance with PDP and ISO14971 risk management.
• Lead continuous improvement projects and support product transfers.
• Collaborate with Manufacturing Engineers to review processes.

Skills

Engineering principles

Root cause analysis

Cross-functional teamwork

Statistical analysis

Education

Bachelor's degree in engineering or related field

Tools

Minitab

Job description

Integer Holdings Corporation seeks an engineer to lead New Product Introduction (NPI) initiatives, applying advanced engineering principles to deliver high-quality products. The role emphasizes QA, regulatory compliance, and cross-functional teamwork across design, manufacturing, and quality teams.

You will develop test methods, perform validation, and participate in risk management per PDP and ISO14971, driving continuous improvement and product transfers in a fast-paced environment.