Manufacturing Process Specialist
hace 3 semanas
Job Summary
At Viant Medical, we are seeking a highly skilled Manufacturing Engineer 3 to join our team. This role will be responsible for managing project responsibilities for new product launches, creating and maintaining technical documentation, and coordinating qualification and validation activities.
Key Responsibilities
- Perform project management responsibilities for assigned tasks, ensuring timely completion and quality delivery.
- Develop, revise, and maintain technical documentation, including Device Master Records and Device History Records, to meet regulatory requirements.
- Coordinate and carry out qualification and validation activities, preparing validation protocols and reports as needed.
- Conduct research and development testing to determine the effectiveness and compliance of manufacturing processes, ensuring conformance to engineering designs and methodologies.
- Develop and coordinate plant layout and installation of new equipment to maximize efficiency and ergonomic standards.
- Coordinate engineering activities with different value streams and suppliers, ensuring effective communication and problem-solving skills.
Requirements
- Bilingual English/Spanish - Advanced English level (written and spoken).
- Knowledge of applicable regulations for the medical device industry, including FDA CFR 820 CGMPs and ISO 13485.
- Knowledge of Six Sigma Methodology (green belt certification) and Lean Manufacturing principles.
- Basic knowledge of Minitab statistical software.
Experience
- 2-4 years of experience in a manufacturing environment, preferably in the medical device or pharmaceutical fields.
- Project management experience, with a focus on quality and compliance.
- At least one year in a current position, with a strong track record of performance and discipline.
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