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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