R&D Additive Manufacturing Process Engineer

4 weeks ago

Fairfield, United States b-ONE Ortho, Corp. Full time

We are seeking a passionate Process Engineer to join our R&D team in Fairfield, New Jersey. This role is crucial in designing, developing, and manufacturing new orthopedic implants using additive manufacturing processes. You will collaborate closely with cross-functional teams to bring innovative orthopedic products from concept to market, ensuring performance, manufacturability, and compliance with global regulatory standards.Key Responsibilities:- Design and develop implants and instruments using SolidWorks 3D CAD, Materialize Magics, and other software as needed.- Participate in cross-functional product development teams, contributing from concept through product launch.- Create working prototypes and iterate designs based on feedback and testing outcomes.- Create and manage Engineering Change Orders (ECOs).- Ensure all designs adhere to GD&T standards (ASME Y14.5-2018) and are optimized for manufacturability (DFM).- Support regulatory submissions by preparing necessary technical documentation.Qualifications:- Bachelor’s degree in Mechanical, Manufacturing, Material Engineering, or a related field.- 5 years of experience in additive manufacturing of medical devices, preferably in orthopedic implants.- Proficiency in 3D CAD modeling, preferably SolidWorks, Magics.- Familiarity with manufacturing processes (machining, forging, casting) and working with external vendors.- Strong understanding of anatomy as it pertains to orthopedic joints is preferred.- Proficiency in GD&T, DFM, and creating regulatory-compliant design documentation.- Strong organizational, verbal, and written communication skills.

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