Senior NPI Engineer II — Onsite Medical Device Launch

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

Job summary

Envista is seeking a Senior New Product Introduction (NPI) Engineer II to drive the development and commercialization of new medical devices. You will collaborate with R&D, QA, Regulatory, Manufacturing, Supply Chain, and Product Management to ensure compliance with quality systems and regulatory requirements while aligning with business objectives.

This onsite role requires four days per week in Pomona, CA.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.
• 7+ years of engineering experience in medical device product development in a regulated environment.
• Experience with verification, validation, design transfer, and production launch in Phase-Gate processes.
• Knowledge of FDA medical device regulations, Design Controls, Quality System requirements, and 510(k) considerations.

Responsibilities

• Collaborate with R&D, QA, Regulatory Affairs, Manufacturing, Product Management, Procurement, and Supply Chain throughout the product development lifecycle.
• Support Phase-Gate development activities and project deliverables.
• Participate in Design Control activities including risk management, verification, and validation.

Skills

Phase-Gate processes

Design Controls

Regulatory compliance

Medical device knowledge

Technical writing

Verbal communication

Problem solving

Organizational skills

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Manufacturing Engineering

Job description

Envista is seeking a Senior New Product Introduction (NPI) Engineer II to drive the development and commercialization of new medical devices. You will collaborate with R&D, QA, Regulatory, Manufacturing, Supply Chain, and Product Management to ensure compliance with quality systems and regulatory requirements while aligning with business objectives.

This onsite role requires four days per week in Pomona, CA.