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.
• Strong knowledge of manufacturing equipment, tools, and processes, particularly in a regulated environment such as medical device manufacturing.
• Ability to quickly identify and resolve production issues, including mechanical, electrical, and process-related problems.
• High attention to detail when performing inspections, quality control checks, and maintaining records to ensure compliance with regulatory requirements.
• Understanding of quality standards and procedures, including ISO 13485, FDA regulations, and other industry-specific requirements for medical device manufacturing.
• Familiarity with Lean Manufacturing, Six Sigma, or other process improvement methodologies to support continuous improvement efforts.
• Ability to work effectively with cross-functional teams, including production, engineering, quality assurance, and maintenance.
• Strong documentation skills, with the ability to maintain accurate records, create reports, and track key performance indicators (KPIs).
• Excellent verbal and written communication skills to interact with team members, managers, and other departments.
• Strong organizational skills and the ability to manage multiple tasks simultaneously while meeting deadlines.
• Knowledge of workplace safety regulations and best practices in a manufacturing environment, particularly in the medical device industry.

Qualifications

• High school diploma or equivalent required. Associate's degree in a technical field (e.g., Manufacturing, Engineering, or related discipline) is preferred.
• Minimum of 2-3 years of experience in a manufacturing or production environment, preferably in the medical device industry or other regulated industries is required.
• Hands-on experience with manufacturing equipment, troubleshooting, and maintenance procedures is required. Familiarity with mechanical, electrical, or electronic systems is preferred.
• Understanding of medical device manufacturing regulations (e.g., FDA 21 CFR 820, ISO 13485), and the ability to adhere to quality standards and compliance requirements is required.
• Ability to lift up to 50 lbs., stand for extended periods, and work in a manufacturing environment that may involve exposure to noise, chemicals, and other physical factors is required.
• Certifications in Lean Manufacturing, Six Sigma, or similar process improvement methodologies are preferred.
• Previous experience in a medical device manufacturing environment, particularly in a role that involved direct production support, equipment maintenance, or troubleshooting are preferred.
• Knowledge of automation, robotics, or specialized manufacturing equipment used in medical device production is preferred.
• Experience leading small teams or mentoring junior technicians is preferred.
• Ability to lift up to 50 lbs. regularly is required.
• Ability to stand, walk, and move around the manufacturing floor for extended periods is required.
• Ability to wear personal protective equipment (PPE) and comply with safety regulations is required.
• Ability to work in an industrial setting, which may include exposure to noise, moving machinery, and other manufacturing-related hazards is required.
• Ability to work occasional overtime to meet production goals or resolve equipment issues is required as needed.