Note: The job is a remote job and is open to candidates in USA. Shoolin Inc is seeking a Mechanical Design Engineer to support the design and development of orthopedic medical devices, particularly extremity implants and surgical instruments. The role involves 3D modeling, assemblies, detailed drawings, tolerance analysis, design documentation, and collaboration with R&D, manufacturing, quality, and regulatory teams throughout product development.
Responsibilities
- Develop and modify 3D CAD models, assemblies, and detailed drawings using Siemens NX
- Design and support orthopedic implants and surgical instruments , including extremity products
- Perform GD&T and tolerance analysis to ensure product quality and manufacturability
- Collaborate with R&D, manufacturing, quality, and regulatory teams
- Participate in design reviews, risk assessments, and design verification activities
- Ensure designs meet applicable FDA and ISO requirements
- Maintain engineering and design documentation in accordance with ISO 13485 and FDA Design Control requirements
- Support product development from concept through manufacturing and verification
Skills
- • Bachelor's degree in Mechanical Engineering or related engineering discipline
- • Strong hands-on experience with Siemens NX for 3D modeling and drafting
- • Experience in medical device design , preferably orthopedic products
- • Experience designing implants, instruments, or other precision medical devices
- • Knowledge of GD&T, tolerance analysis, and design for manufacturability
- • Understanding of materials such as metals and polymers
- • Knowledge of manufacturing processes such as CNC machining and additive manufacturing
- • Familiarity with FDA regulations and ISO 13485/design controls
- • Experience with Teamcenter or other PLM systems
- • Experience with orthopedic extremities such as knee, hip, or shoulder products
- • Understanding of biomechanics and anatomical considerations in medical device design
- • Experience supporting design verification, risk management, and design reviews
- • Strong communication, collaboration, and problem-solving skills
Benefits
- United States (Remote)
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