Ormco Senior New Product Implementation Engineer II (Pomona, CA)
Core
Senior engineer supporting new product development and commercialization from feasibility through launch for medical devices.
Role type
Senior IC new product introduction (NPI) engineer
Builds
Medical device products (orthodontic solutions)
Domain
Medical devices / Orthodontics
Required skills
mechanical engineering, biomedical engineering, manufacturing engineering, verification and validation, design control, risk management, design transfer, regulatory compliance (FDA), technical writing, project planning
Preferred skills
EU MDR requirements, ISO 13485, ISO 14971, Design for Manufacturability (DFM), Design for Assembly (DFA), electro-mechanical product development
Technologies
Envista Business Systems (EBS)
Responsibilities
Collaborate with R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams; support Phase-Gate development activities; participate in Design Control activities including risk management and verification; develop and execute engineering studies and test protocols; support design transfer and commercialization; provide technical guidance to junior engineers
Seniority
Senior, hands-on IC