Ormco Senior New Product Implementation Engineer II (Pomona, CA)

Envista Dentistry•Pomona, CA

2d•Onsite

About The Position

The Senior New Product Introduction (NPI) Engineer II supports new product development and commercialization from feasibility through product launch. The role works closely with Research & Development, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, Product Management, and Procurement to help ensure products meet company quality-system, regulatory, and business requirements. The position supports Phase-Gate development and Design Control activities, including planning, reviews, risk management, verification and validation, design transfer, and change management. It also contributes to engineering studies, testing, project planning, commercialization, and production launch, while providing technical guidance to junior engineers and technicians as needed. The selected candidate must live within commuting distance of Pomona, California. The role is not hybrid or remote and requires onsite presence four days per week.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
At least 7 years of engineering experience in medical device product development, new product introduction, quality engineering, manufacturing engineering, or a related discipline in a regulated environment.
Demonstrated experience supporting medical device products through verification, validation, design transfer, commercialization, and production launch within a Phase-Gate or similar product development process.
Experience participating in Design Control activities, including risk management, design reviews, verification and validation, traceability, and design transfer.
Strong technical writing, verbal communication, problem-solving, and organizational skills.
Medical device industry experience and working knowledge of FDA medical device regulations, including Design Controls, Quality System requirements, and 510(k) product development considerations.
Must reside within a commutable distance of Pomona, California and be able to work onsite four days per week.

Nice To Haves

Understanding of EU MDR requirements and their impact on product development, risk management, verification and validation, and technical documentation.
Familiarity with FDA requirements, EU MDR, ISO 13485, and ISO 14971.
Understanding of Design for Manufacturability (DFM), Design for Assembly (DFA), and Design Transfer principles.
Electro-mechanical product development experience, including integration of mechanical components with motors, sensors, actuators, electronics, controls, or other electromechanical systems.

Responsibilities

Collaborate with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, Product Management, Procurement, and Supply Chain throughout the product development lifecycle.
Support product teams through Phase-Gate development activities and associated project deliverables.
Participate in Design Control activities, including development planning, design reviews, risk management, verification, validation, design transfer, and change management.
Assist project teams in meeting internal quality-system requirements and applicable regulatory requirements.
Develop, execute, and document engineering studies, test methods, protocols, and technical reports for product development activities.
Support verification and validation testing to demonstrate compliance with product requirements and design specifications.
Support design transfer and collaborate with Manufacturing, Quality, and Supply Chain during commercialization.
Contribute to project planning, milestone tracking, and development deliverables.
Provide technical guidance and mentorship to junior engineers and technicians as needed.