R&D Additive Manufacturing Process Engineer

7 days ago

Fairfield NJ, United States b-ONE Ortho, Corp. Full time $80,000 - $120,000 per year

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 Y 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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