Senior NPI Engineer II - Medical Devices, Onsite (4 days)

Ormco; Pomona (CA); On-site; USD 115,000 - 141,000; Full time

Job summary

Envista is seeking a Senior New Product Introduction (NPI) Engineer II in Pomona, CA. This onsite role collaborates with R&D, QA, regulatory, manufacturing, and product management to advance new product development and commercialization in compliance with quality systems and regulatory requirements.

The candidate will participate in design control, verification/validation, risk management, and design transfer, guiding projects through Phase-Gate processes and supporting commercialization

Qualifications

• 7+ years of engineering experience in medical device product development or related disciplines.
• Experience supporting medical device products through verification, validation, and design transfer in a Phase-Gate or similar process.
• Proven ability in design control activities, risk management, verification/validation, and design transfer.

Responsibilities

• Collaborate with R&D, QA, regulatory, manufacturing, product management, and supply chain across the product development lifecycle.
• Support Phase-Gate development activities and project deliverables.
• Participate in Design Control activities including planning, reviews, risk management, verification, validation, and transfer.
• Assist teams in meeting quality system and regulatory requirements.
• Develop, execute, and document engineering studies, tests, protocols, and reports.

Skills

Project management

Design controls

Regulatory affairs

Medical device engineering

Verbal communication

Education

Bachelor's degree in Mechanical Engineering

Job description

Envista is seeking a Senior New Product Introduction (NPI) Engineer II in Pomona, CA. This onsite role collaborates with R&D, QA, regulatory, manufacturing, and product management to advance new product development and commercialization in compliance with quality systems and regulatory requirements.

The candidate will participate in design control, verification/validation, risk management, and design transfer, guiding projects through Phase-Gate processes and supporting commercialization