◈ 직무 개요
- 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 요건
* 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.
* 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.
◈ 처우
- Negotiable
◈ 제출 기한
- ASAP
◈ 제출 서류 및 기타
- 국/영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 이건교 / 02-2016-6602 / at6gule1@vpeople.co.kr