Manufacturing Supervisor

TransMedics, Inc.•Andover, MA

About The Position

Position Overview: The Manufacturing Supervisor is responsible for managing and coordinating the daily operations of the manufacturing floor, ensuring that production targets, quality standards, and safety protocols are met. This role involves leading a team of operators and technicians, optimizing production processes, and driving continuous improvement initiatives.

Requirements

Bachelor’s degree or commensurate experience.
7+ years of experience in a manufacturing clean room environment in the medical device industry.
3+ years of supervisory or leadership experience.
Demonstrated understanding of cGMP execution.
Strong understanding of manufacturing processes, quality standards, and regulatory requirements.
Excellent leadership, communication, and interpersonal skills.
Ability to analyze data, solve problems, and make sound decisions.
Proficient in using manufacturing software and Microsoft Office Suite.

Responsibilities

Supervise, mentor, and motivate a team of manufacturing operators and technicians.
Conduct regular team meetings to communicate goals, expectations, and performance feedback.
Oversee daily production activities to ensure that production schedules are met.
Monitor and analyze production metrics to identify areas for improvement.
Coordinate with other departments (e.g., Quality, Engineering, Supply Chain etc) to resolve production issues.
Ensure that all products meet the company’s quality standards and regulatory requirements.
Implement and enforce standard operating procedures (SOPs), Manufacturing Instructions (MI’s) and quality control processes.
Participate in quality audits and drive corrective actions to address non-conformities.
Identify and implement process improvements to increase efficiency, reduce waste, and lower costs.
Utilize lean manufacturing techniques to optimize production processes.
Ensure compliance with all regulatory requirements, including FDA, ISO 13485, and OSHA standards.
Conduct regular safety inspections and training sessions for the team.
Manage inventory levels and ensure the availability of necessary materials and equipment.
Coordinate with the maintenance team to schedule equipment maintenance and repairs.
Prepare and maintain accurate production reports, records, and documentation.
Analyze production data and provide regular updates to the Manufacturing Manager.
Assist in the preparation of production plans and forecasts.