Accountable for existing processes sustaining for the applicable areas.
Also, is responsible of development and continuous improvement of manufacturing processes.
May have complete project responsibility for significant projects within specialized area and participate in the activity's execution of the VIP's Projects.Key Responsibilities:
- Apply experience, training and acquired engineering techniques to solve problems.
- Direct participation in Daily Management system Tier II and process accountability for sustaining activities of all applicable areas.
- Participate in project planning and may direct portions of smaller projects or segments of large projects to include scheduling, monitoring costs, resources, workforce loading, etc.
- Experience in Movement and time study to improve efficiency in production lines.
- Design and implement manufacturing cells focus on ergonomic, productivity and Quality.
- Implement quick improvements acting as leader in kaizen blitz events promote process improvement culture.
- Design and implementation of production fixtures/tools and inspection equipment as required.
- Capacity (equipment, labor, space) and maintenance planning and strategies.
- Production yield, productivity, downtime tracking and corrective action.
- Coordination of activities related to manufacturing transfer to new manufacturing site.
- Development and completion of process validation, while ensuring that changes made to specifications, methods, processes or procedures are verified or, where appropriate, validated according to standard operating procedures and QSR's element 820.75, before implementation.
- Participates in CPE projects, and product and process validation and verification according to quality system procedures.
- May lead or participate with organizational and group operations' management in CAPA activities by conducting, determining and verifying corrective actions necessary to ensure continued compliance with division policy and procedures, Federal regulations under Title 21 CFR Part 820, and ISO 13485.Required Background:
- Four + years experience in a related position.
- Mechanical Engineer, Mechatronic Engineer, Electrical Engineer, Electromechanic Engineer, Systems Engineer or similar.
- Experience in problem solving, project management, lean practices, six sigma, line transfers.
Experience working in ISO / FDA regulated environments and GMP's.
- Medical companies as a plus
- Extrusion experience as a plus
- Bilingual: Oral and written communication in English requiredUnete a nuestro Equipo de Trabajo, envia tu CV a Joel Mercado ****** #J-18808-Ljbffr