* Job Overview
The Senior/Principal Mechanical Engineer will play a critical role in the design, development, and implementation of innovative robotic systems for medical applications. This position requires a deep understanding of mechanical engineering principles, robotics, and medical device regulations and best practices. Title will be commensurate with experience level.
* Duties / Responsibilites
• Contribute to the design and development of mechanical components and subsystems for robotic medical devices.
• Create detailed CAD models and engineering drawings using software such as SolidWorks, AutoCAD, or similar.
• Develop prototypes and oversee their testing to ensure design feasibility and performance.
• Collaborate with cross-functional teams including electrical engineers, software engineers, and clinical specialists to integrate mechanical designs with other system components.
• Conduct rigorous testing and validation of mechanical systems to ensure they meet regulatory and safety standards.
• Analyze test data and iterate designs based on findings to optimize performance and reliability.
• Prepare comprehensive technical documentation, including design outputs, tolerance stack analyses, FEA analyses, design specifications, test protocols, and reports.
• Ensure all designs comply with relevant medical device regulations and standards (e.g., ISO 13485, ISO 14971, FDA).
• Stay current with advancements in robotics and medical device technology to incorporate cutting-edge solutions into product designs.
• Identify opportunities for innovation and continuous improvement in existing products and processes.
• Engage in risk management activities including FMEA and designing and implementing risk controls.
• Contribute to requirements, prototyping, testing, and assembly efforts for the mechanical components and subsystems.
경력 및 자격요건
* Education and Experience
• Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, Robotics, Aerospace Engineering, or a related field.
• Minimum 5 years of experience (preferably 10) in the design and manufacturing of regulated products such as medical devices, automotive, or aerospace, with a preference for robotic systems.
• Proficiency in verbal and written English preferred.
* Required Skills / Abilities
• 5+ years of mechanical design experience in a regulated industry.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD).
• Strong understanding of mechanical design principles, materials, and manufacturing processes.
• Experience with FEA (Finite Element Analysis) and other simulation tools.
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.
• Project management skills with the ability to handle multiple projects simultaneously.
* Preferred Skills / Abilities
• 10+ years of mechanical design experience in a regulated industry.
• Strong knowledge of manufacturing processes, equipment, and tooling.
• Hands-on capability in a lab/production setting and able to function comfortably as an mechanical technician to troubleshoot and assemble product. Ability to train technicians preferred.
• Excellent problem-solving skills and ability to troubleshoot and resolve manufacturing issues.
• Strong attention to detail, organizational skills, and ability to manage multiple tasks and project simultaneously.
• Familiarity with regulatory requirements and standards (FDA, ISO) for medical devices.
* Physical Requirements
• Prolonged periods of sitting at a desk and working on a computer.
• Occasional periods of standing.
• Must be able to lift 25 pounds at a time.
• Occasional assembly and prototyping work in a laboratory or production setting
• Must be able to occasionally collaborate with team members across different time zones including Houston, TX, USA.
담당업무
02-6281-5027
jjh@nterway.com
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