PURPOSE OF JOB

Collaborate with Operations to implement improvement opportunities in the process to ensure production goals are achieved. Collaborate with the transfer of products to manufacture and ensure a high degree of process capability. Validate process changes with documentation and necessary approvals.

JOB OPERATION/ELEMENTS

Responsibilities

• Supports Production area in troubleshooting process and deliver timely solutions for product development.
• Responds quickly to the occurrence of defects and unplanned production downtimes due to equipment failures, process issues. Solves related problems to resume production.
• Leads a team to investigate the root causes of process problems and implements corrective actions. Develops procedures to ensure product quality / process capability and reduces process variability ensuring consistency in Mfg. execution.
• Reviews/Develops procedures to ensure accuracy and upgrades required by change orders in the documentation. Works with Production to develop production processes, standard operating procedures, and drawings.
• Has relationships with R&D, sourcing, and supplier engineering to pursue new development projects as well as seek cost improvements on existing products.
• Attends daily shift meetings and communicates by providing updates with various departments.
• Performs nonconformance and corrective actions investigation from root cause all the way to effectiveness.
• Responsible for creating, routing and execution of all engineering reports, including all the validation phases as of engineering studies, process development, installation, operational and performance qualifications.
• Informs project status to all levels of organization, including performance, cost, and schedule updates.
• Utilizes DMAIC, OpEx, and mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’.
• Facilitates ease of manufacturing to produce quality, cost effective products with optimized yields.
• Evaluates/Changes existing product flow, investigates and identifies new technology developments including automation-based solutions, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies.
• Develops budget and schedule for projects and manages them.
• Monitors daily/weekly/monthly product key metric trends and develops action plans as required (i.e. scrap, equipment downtime).
• Determine parts and tools needed, and its controls in order to achieve manufacturing goals and reduce costs.
• Collaborate with the development and transfer of products. Manage the installation and proper performance of new processes and equipment.
• Conduct verification and validation of new processes and modifications to ensure process capability.
• Other functions might be assigned based on company’s needs.

REQUIREMENTS EDUCATION:

• Bachelor in Engineering or Manufacturing
• Bilingual: English and Spanish B2 level minimum
• Postgraduate degree preferred

EXPERIENCE:

• Minimum 7 years in a medical device manufacturing environment.
• Experience with GMPs and ISO 13485 a plus.
• Validation execution experience, process characterization, IQ, OQ, PQ
• Desirable transfer experience