Clean Room Lead

Primary Objective

• Oversees and coordinates manufacturing, packaging, and labeling processes in a clean room environment ensuring employee safety, delivery deadlines, ISO 13485 document compliance, and quality objectives are met. Leads team members to execute manufacturing requirements through training and feedback.
• Leads the team to execute manufacturing steps across various production areas according to documented procedures. Analyzes machine, process, or personnel issues and corrects, or gives suggestions on appropriate corrective actions. Provides leadership and training to team members.

Essential Duties and Responsibilities

• Can meet or exceeds all responsibilities of a “Clean Room Operator”
• Adhere to and reinforce clean room environmental standards and safety absolutes, ensuring team compliance and promoting a culture of safety.
• Maintain an in-depth understanding of all production processes, regularly auditing compliance
• Identify and communicate continuous improvement opportunities through leadership or engineering
• Develop and maintain positive working relationships with employees, peers, and managers, interfacing with other departments to ensure effective communication and professionalism.
• Provide clear direction to the team regarding daily, weekly, or monthly expectations.
• Analyze production resources availability to meet daily goals and escalating concerns as needed.
• Train or aid in the training of personnel on manufacturing processes.
• Assist in developing written procedures.
• Ensure material availability for production.
• Use ERP systems as established to maintain production flow and proper record keeping
• Monitor and audit in-process quality.
• Review and complete production traceability forms.
• Support team members in maintaining high levels of quality and productivity.
• Assign responsibilities to maintain a clean and organized working environment.
• Conduct appropriate line-clearance activities to maintain product traceability.
• Lead RCA activities within production groups to quickly identify and address production problems.

Qualifications: Knowledge, Skills, Education and Experience

• Ability to manufacture catheters and be cross trained to multiple stations inside the cleanroom.
• Requires capability with a computer to fill out production reports, utilize Microsoft Teams, and Outlook to communicate with leadership and other departments.

Work Environment

• Operates in a class 7 cleanroom environment
  • • Requires gloves, smocks, hairnets, beard covers.
    • Other requirements as designated in the employee dress code and SOP’s
• Safety shoes required
• Safety glasses required
  • Other PPE required per the station or project requirements including, but not limited to cut resistant gloves, face shields, hot working gloves, and ear protection.

Physical demands

• Walking/standing up to 80% of shift
• Sitting up to 60% of shift
• Lifting up to 30 lbs, pulling up to 30 lbs, pushing up to 30 lbs
• Requires regular twisting, bending and kneeling up to 30% of shift
• Repetiti