◈ 직무 개요
- Oversee the production line(s) and production efforts.
- Manage and maintain clean room operations.
- Develop and maintain process documentation, including standard operating procedures, work instructions, and process flow diagrams.
- Maintain knowledge of design prints and approvals to ensure compliance and adherence to presented design prints.
- Design and develop manufacturing and procedures for medical device production.
- Collaborate with R&D on design changes, approvals and implementation.
- Develop and maintain detailed manufacturing plans, schedules, and budgets to ensure timely delivery of products.
- Conduct process improvement projects to optimize efficiency, reduce costs, and improve quality.
- Collaborate with cross-functional teams including design, quality, and production to ensure successful product launch.
- Perform root cause analysis and implement corrective actions to resolve production issues.
- Stay up to date on industry trends, technologies, and regulations related to medical device manufacturing.
◈ 경력 요건
* Required Skills/Abilities
- Demonstrated ability to manage complex medical device components.
- Familiarity with quality standards such as ISO 13485 and FDA regulations.
- Strong problem-solving and analytical skills.
- Excellent communication and teamwork skills and the ability to work cross-functionally.
- Ability to work independently, under pressure, and to handle multiple projects and tight deadlines simultaneously.
- Knowledge of FDA Good Manufacturing Practices, ISO 13485 and 14971, 510k and Standards within Medical Devices.
- Has experience in working in high performance organizations and fostering a positive culture with a high degree of accountability and integrity.
- Ability to concisely communicate status, needs, forecasts, risks, and timelines effectively to executive team and all levels of the organization (one-on-one and large groups).
- Strategic and critical thinker with the ability to analyze, understand and effectively communicate technical material to all levels of the organization.
* Education and Experience
- Bachelor’s degree in mechanical, industrial, or manufacturing engineering, or related field.
- Minimum 3 years of experience in assembly line development and management.
- Strong knowledge of manufacturing processes, equipment, and tooling.
◈ 처우
- Negotiable
◈ 제출 기한
- ASAP
◈ 제출 서류 및 기타
- 국/영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 이건교 / 02-2016-6602 / at6gule1@vpeople.co.kr