Senior NPI Quality Engineer – Process & Compliance Leader

Regulatory Jobs; Brooklyn Park (MN); Sur place; USD 96 000 - 125 000; Plein temps

Résumé du poste

Integer is seeking an experienced engineer to drive New Product Introductions with a strong focus on quality and regulatory compliance. You will apply advanced engineering principles to develop and validate new products, lead cross-functional teams, and ensure adherence to PDP and ISO14971 risk management requirements.

The role requires 5+ years of engineering experience, plus hands-on use of Minitab for data analysis and a demonstrated ability to communicate technical concepts clearly with

Qualifications

• Bachelor’s degree in engineering or related field; master's preferred.
• 5+ years of progressive engineering experience.
• Experience with ISO/QSR, regulatory knowledge is preferred.
• Strong problem-solving and communication skills.

Responsabilités

• Apply engineering principles to New Product Introduction projects.
• Lead cross-functional NPI team and participate in PDP reviews.
• Ensure compliance with PDP and ISO14971 risk management.
• Develop test methods, design tooling, fixtures and templates.
• Conduct studies and provide technical guidance to management.
• Support regulatory inspections and audits.

Connaissances

Statistics

Problem solving

Team collaboration

Communication

Formation

Bachelor's degree in engineering or related field

Master's degree (preferred)

Outils

Minitab

Excel

Description du poste

Integer is seeking an experienced engineer to drive New Product Introductions with a strong focus on quality and regulatory compliance. You will apply advanced engineering principles to develop and validate new products, lead cross-functional teams, and ensure adherence to PDP and ISO14971 risk management requirements.

The role requires 5+ years of engineering experience, plus hands-on use of Minitab for data analysis and a demonstrated ability to communicate technical concepts clearly with