Manufacturing Engineer III
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- 회사개요 : 외국계 의료기기 제조업체
- 모집기간 : 채용시까지
◈ 직무 개요
- Lead the development, implementation, and optimization of manufacturing processes for surgical robotic instruments, including production line setup, assembly, testing, and packaging.
- Collaborate with R&D, Quality, and Operations teams to ensure manufacturability and facilitate the seamless integration of new products into production, including involvement in operator training.
- Design and develop tooling, fixtures, and equipment to enhance manufacturing efficiency and effectiveness, ensuring compliance with Good Documentation Practices (GDP) for all related documentation (e.g., design inputs, BoMs, specifications, drawings and 3D models).
- Conduct fixture and process validations, ensuring all documentation meets FDA/ISO, and other regulatory standards.
- Identify and implement process improvements to reduce costs, improve quality/safety, and increase production throughput.
- Troubleshoot and resolve production issues, providing technical support to overcome manufacturing challenges.
- Lead cross-functional teams in root cause analysis and the implementation of corrective and preventative actions in a fast-paced environment.
- Manage projects from concept to production launch, ensuring timely completion within budget and quality standards.
- Author and maintain risk management documentation related to manufacturing processes, including PFMEA.
- Design and develop tooling, fixtures, and equipment to enhance manufacturing efficiency and effectiveness, ensuring compliance with Good Documentation Practices (GDP) for all related documentation (e.g., design inputs, BoMs, specifications, drawings and 3D models).
- Conduct fixture and process validations, ensuring all documentation meets FDA/ISO, and other regulatory standards.
- Identify and implement process improvements to reduce costs, improve quality/safety, and increase production throughput.
- Troubleshoot and resolve production issues, providing technical support to overcome manufacturing challenges.
- Lead cross-functional teams in root cause analysis and the implementation of corrective and preventative actions in a fast-paced environment.
- Manage projects from concept to production launch, ensuring timely completion within budget and quality standards.
- Author and maintain risk management documentation related to manufacturing processes, including PFMEA.
◈ 경력 요건
* Required Skills/Abilities
- Proven track record of developing and optimizing manufacturing processes for medical devices.
- Strong knowledge of FDA and ISO regulatory requirements and documentation related to medical device manufacturing.
- Proficiency in CAD software (Solidworks preferred), process simulation, and lean manufacturing principles.
- Expertise in the design and development of complex assembly fixtures.
- Excellent project management, communication, and leadership skills.
- Ability to work both independently and as part of a team in a dynamic environment.
* Preferred Skills/Abilities
- Strong knowledge of FDA and ISO regulatory requirements and documentation related to medical device manufacturing.
- Proficiency in CAD software (Solidworks preferred), process simulation, and lean manufacturing principles.
- Expertise in the design and development of complex assembly fixtures.
- Excellent project management, communication, and leadership skills.
- Ability to work both independently and as part of a team in a dynamic environment.
* Preferred Skills/Abilities
- Experience in flexible endoscope manufacturing highly preferred.
- Familiarity with cable driven mechanisms, tensile testing and related fixtures.
- Hands-on fabrication and manufacturing experience (e.g., machining, injection molding, 3-D printing, laser welding, soldering, etc.)
- Proficiency in written and verbal communication in English is preferred.
* Education and Experience
- Familiarity with cable driven mechanisms, tensile testing and related fixtures.
- Hands-on fabrication and manufacturing experience (e.g., machining, injection molding, 3-D printing, laser welding, soldering, etc.)
- Proficiency in written and verbal communication in English is preferred.
* Education and Experience
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- Minimum of 5 years of experience in manufacturing engineering within the medical device industry, with specific experience in robotic systems strongly preferred. 8 years or more of experience preferred.
- Minimum of 5 years of experience in manufacturing engineering within the medical device industry, with specific experience in robotic systems strongly preferred. 8 years or more of experience 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
`25.04.21(updated. `25.04.21)