◈ 직무 개요
- Lead the development and manufacturing of medical device robotics specifically focusing on instruments, EndoDrive, and accessories.
- 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.
- Provide strategic direction and leadership for the team, ensuring the successful execution of projects within budget and timeline constraints.
- Collaborate with cross-functional teams including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure the successful development and implementation of new robotic technologies.
- 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 specifications, test protocols, and reports.
- Ensure compliance with all relevant regulatory requirements and standards, including FDA regulations, ISO standards, and Good Manufacturing Practices (GMPs).
- Identify opportunities for innovation and continuous improvement in existing products and processes.
◈ 경력 요건
* Required Skills/Abilities
- 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.
- Excellent analytical and strategic thinking skills.
- Strategic thinker with the ability to analyze, understand and effectively communicate deep technical material to all levels of the organization.
- Must be a detail and goal orientated, self-motivated individual with the ability to multi-task.
- Ability to travel internationally.
* Preferred Skills/Abilities
- Strong understanding of GMP’s, FDA regulations, and ISO standards related to medical device manufacturing.
- Experience in the development and implementation of robotic technologies for medical devices preferred.
- Great interpersonal skills and works well across the matrix with cross-functional teams in Quality, Regulatory, Operations, Engineering, and others.
Education and Experience
- Bachelor’s degree or advanced in Mechanical Engineering or related field.
- At least 8 years of experience in medical device engineering, with a focus on robotic technologies and/or instruments, EndoDrive, and camera systems.
◈ 처우
- Negotiable
◈ 제출 기한
- ASAP
◈ 제출 서류 및 기타
- 국/영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 이건교 / 02-2016-6602 / at6gule1@vpeople.co.kr