Ormco Senior New Product Implementation Engineer II (Pomona, CA)
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, Procurement, and Product Management to help ensure products meet company quality-system and regulatory requirements and business objectives. The position supports Phase-Gate development and Design Control activities, including development planning, design reviews, risk management, verification, validation, design transfer, and change management. It also develops and documents engineering studies, test methods, protocols, and technical reports; supports testing and commercialization; and contributes to project planning and milestone tracking. The role is onsite in Pomona, California, four days per week, and the selected candidate must live within commuting distance.
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 commuting 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, 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 in support of product development.
- 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.
Benefits
- Medical, dental, and vision benefits.
- 401(k) match.
- The compensation package may include an annual performance bonus and other applicable compensation plans.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
