R&D Additive Manufacturing Process Engineer

4 weeks ago


Fairfield Essex County NJ, 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: - Bachelors 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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