| :: 미국계 전자 의료기기 회사 - 시니어/수석 Mechanical Engineer :: | |
| Company Introduction | 미국계 전자 의료기기 회사 |
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| Job Description | * 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. |
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| Job Requirement | * 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. |
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| Location | 경기(성남시)|경기(성남시) | Degree Level | 제한없음 |
| Career Level | [부장급][차장급] | ||
| No. of Recruitment | 1 | ||
| Salary | 협의 | ||
| Required Document | 이력서, 경력기술서, 자기소개서 (영문 포함) | ||
| Others | - 원서 마감후 1차(서류) 합격자에 한하여 개별연락 - 해외여행에 결격 사유가 없는 자 - 이력서에 연락처, 희망연봉 게재 |
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| Contact/Inquiry | 장재혁 / 이사 02-6281- 5027 jjh@nterway.com |
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