Mechanical Engineer I - Instruments & Accessories
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- 모집기간 : 채용시까지
◈ 직무 개요
Duties/Responsibilities
- Assist in the research, design, and development of apparatuses and equipment for testing and prototyping.
- Follow GDP (Good Documentation Practices) for design history including design review, protocols, reports, and drawings.
- Gather clinical inputs then implement in the design output.
- Lead root cause analysis and provide solutions in a fast-paced environment.
- Design and conduct mechanical testing.
- Interpret and report mechanical testing findings for verification and validation.
- Work as part of a team of Mechanical Engineering staff to bring designs through prototyping and into serial production.
- Maintain positive and collaborative relationships with vendors and suppliers.
- Hands-on fabrication and assembly for prototyping required.
- Assist in the research, design, and development of apparatuses and equipment for testing and prototyping.
- Follow GDP (Good Documentation Practices) for design history including design review, protocols, reports, and drawings.
- Gather clinical inputs then implement in the design output.
- Lead root cause analysis and provide solutions in a fast-paced environment.
- Design and conduct mechanical testing.
- Interpret and report mechanical testing findings for verification and validation.
- Work as part of a team of Mechanical Engineering staff to bring designs through prototyping and into serial production.
- Maintain positive and collaborative relationships with vendors and suppliers.
- Hands-on fabrication and assembly for prototyping required.
◈ 경력 요건
Required Skills/Abilities
- Advanced 3D modeling.
- Knowledge of design for manufacturability.
- Intermediate Mechanical Design, Machine Design, or equivalent experience.
- Advanced 3D modeling.
- Knowledge of design for manufacturability.
- Intermediate Mechanical Design, Machine Design, or equivalent experience.
Preferred Skills/Abilities
- Experience in 3D modeling of electro-mechanical systems.
- Experience with finite element analysis and complex tolerance analysis.
- Experience with rapid prototyping.
- Capital and Disposable medical device design experience.
- Machining experience.
- Robotics/kinematics knowledge.
- Experience engaging with physician customers to discuss and evaluate design concepts to drive innovation.
- Experience in the development and commercialization of medical device products.
- Ability to review and critically assess patents and other forms of intellectual property.
- Experience with Advanced 3D modeling, IEC 60601.
- Familiarity with FDA GMP/ISO 13485, 14971 standards for medical devices.
- Familiarity with 21 CFR 820.
- Familiarity with testing standards such as ASTM.
Education and Experience
- A Bachelor’s degree or advanced degree in Mechanical Engineering, Industrial Engineering, or a related field.
- 1~3 years of industrial experience.
◈ 제출 서류 및 기타
- 국/영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 이건교 / 02-2016-6602 / [email protected]
3시간 전