Technician

Reporting to the Value Stream Manager, the Technician is responsible for supporting the efficient operation of manufacturing processes in the value stream, ensuring that production goals are met while maintaining high standards of quality and compliance. The Technician will work closely with the Value Stream Manager, production teams, and other stakeholders to monitor and optimize processes, troubleshoot equipment and production issues, and maintain accurate records. Additionally, the Technician will contribute to continuous improvement initiatives, assist with training new employees, and ensure that all processes meet regulatory requirements in the production of medical devices.

Major Responsibilities

·        Support the daily operations of the value stream by assisting in the setup, operation, and troubleshooting of equipment and machinery used in the production of medical devices.

·        Perform routine maintenance and calibration of equipment to ensure it operates within specifications and meets production schedules.

·        Monitor the production process to ensure efficiency and output quality, identifying and addressing issues as they arise.

·        Assist in the preparation of workstations, tools, and equipment for production, ensuring proper setup and minimizing downtime.

·        Diagnose and resolve issues related to machinery, equipment, and production processes in a timely manner to minimize downtime and maintain production targets.

·        Collaborate with engineering and maintenance teams to address more complex issues and implement solutions to improve process stability and efficiency.

·        Document any issues, solutions, and actions taken for troubleshooting and process improvement.

·        Conduct quality checks and inspections during production to ensure that all products meet the required specifications and comply with company and regulatory standards (e.g., FDA, ISO 13485).

·        Assist in maintaining accurate records of inspections, tests, and other quality control documentation required for medical device manufacturing.

·        Ensure that all manufacturing activities comply with established standard operating procedures (SOPs), safety regulations, and quality management system (QMS) requirements.

·        Participate in root cause analysis and corrective action processes when deviations or non-conformances are identified.

·        Contribute to continuous improvement initiatives in the value stream by identifying opportunities to optimize processes, reduce waste, and improve product quality.

·        Participate in Lean Manufacturing, Six Sigma, or other process improvement activities aimed at increasing efficiency and reducing costs.

·        Support the implementation of process changes and improvements, working with the Value Stream Manager and cross-functional teams.

·        Maintain accurate and up-to-date records of production activities, machine setups, maintenance, inspections, and test results.

·        Prepare and submit reports as required, tracking key performance indicators (KPIs) such as downtime, production output, and quality metrics.

·        Assist with the development of work instructions, standard operating procedures (SOPs), and training materials for the value stream team.

·        Provide training and guidance to new and existing team members on production processes, safety procedures, equipment operation, and troubleshooting techniques.

·        Ensure that all team members follow proper procedures and safety protocols during their work in the value stream.

·        Act as a mentor or lead technician for less experienced team members, helping them develop their skills and knowledge.

·        Ensure that all work areas are maintained in a clean, organized, and safe manner, adhering to company policies and industry safety standards.

·        Follow and enforce all safety protocols, including the use of personal protective equipment (PPE) and adherence to lockout/tagout (LOTO) procedures.

·        Participate in safety audits, risk assessments, and safety meetings to ensure a safe working environment.

·        Perform other duties as assigned.