Senior NPI Engineer II – Medical Devices, Onsite

envista; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Envista in Pomona, CA is seeking a Senior New Product Introduction Engineer II to support new product development from feasibility to launch; collaborates with R&D, QA, Regulatory, Manufacturing, and more to ensure quality systems and regulatory compliance.

Requires 7+ years in medical device development, hands-on design control, verification/validation, and design transfer; on-site four days a week.

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• 7+ years of medical device development experience.
• Experience with verification, validation, design transfer, and product launch.
• Knowledge of FDA medical device regulations (Design Controls, QSR).

Responsibilities

• Collaborate across R&D, QA, regulatory, manufacturing, and supply chain.
• Support Phase-Gate development activities and deliverables.
• Lead design control activities including planning, reviews, risk management.
• Document studies, tests, reports to support development.
• Mentor junior engineers and technicians.

Skills

Medical device experience

Phase-Gate process

Design Control

Verbal communication

Technical writing

Risk management

Education

Bachelor's degree in Engineering

Job description

Envista in Pomona, CA is seeking a Senior New Product Introduction Engineer II to support new product development from feasibility to launch; collaborates with R&D, QA, Regulatory, Manufacturing, and more to ensure quality systems and regulatory compliance.

Requires 7+ years in medical device development, hands-on design control, verification/validation, and design transfer; on-site four days a week.