Job Title: Manufacturing Lead

Job Description

The Manufacturing Lead oversees the efficient, accurate, safe, and timely manufacturing of regulated products, including medical devices of a radioactive nature. This role provides daily direction and leadership to Manufacturing Technicians, communicates the needs and capabilities of the assigned area to leadership, and, when needed, operates manufacturing equipment and in‑process instrumentation. The position follows established instructions and guidelines, applies good documentation practices and statistical techniques, and drives continuous improvement across manufacturing processes. The Manufacturing Lead also mentors and coaches team members while ensuring strict adherence to quality, regulatory, and safety requirements.

Responsibilities

• Perform all work in full compliance with company policies and within the guidelines of the Quality System and applicable regulatory requirements.
• Provide clear daily direction to team members in the assigned area to ensure products are manufactured on time and in accordance with all relevant policies and procedures.
• Manufacture, assemble, and ship regulated products and sub‑assemblies, including medical devices that are radioactive in nature, following Good Manufacturing Practices and Standard Operating Procedures.
• Operate production and manufacturing equipment within controlled environments, ensuring proper setup, operation, and shutdown in line with established protocols.
• Maintain accurate and complete records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
• Review and verify timecards for team members to ensure accuracy and compliance with company policies.
• Support training and progression of Manufacturing Technicians by providing guidance, clarifying instructions, and reinforcing pre‑established written guidelines for job functions.
• Escalate employee relations concerns and support regular check‑ins and one‑on‑one discussions with team members as needed to maintain a positive and productive work environment.
• Maintain organization and cleanliness of all designated manufacturing areas, ensuring that workspaces meet safety and quality standards.
• Assist with in‑process testing to verify that batches meet specifications and quality requirements, and document results according to procedures.
• Identify opportunities to improve processes, tooling, production equipment, assembly methods, materials, and parts to enhance efficiency, quality, and safety.
• Assist with maintenance activities on manufacturing and laboratory equipment as directed, helping to minimize downtime and support reliable operations.
• Provide mentorship and coaching to Manufacturing Technicians, fostering skill development, adherence to best practices, and a culture of continuous improvement.
• Embody the company’s purpose and shared values, contributing to a positive, collaborative, and high‑performing team culture.
• Comply with all company policies and procedures, including quality, safety, and operational guidelines.
• Follow all safety rules and precautions, especially when working in controlled environments and with hazardous or radioactive materials.
• Access employee and/or patient PHI and ePHI only as needed for job‑related functions, and handle such information in accordance with privacy and security requirements.
• Become an authorized user of one or more areas in the facility as required for manufacturing operations and regulatory compliance.
• Perform other duties as assigned to support manufacturing operations and organizational goals.

Essential Skills

• High school diploma or equivalent is required; an associate’s degree in a technical field is preferred.
• Minimum of 5 years of manufacturing or operations experience, with at least 1 year of medical device manufacturing experience preferred.
• Experience handling radioactive materials in a radiation‑controlled environment is preferred.
• Supervisory or lead experience in a manufacturing setting is preferred.
• Proven ability to effectively communicate tasks and instructions from management to Manufacturing Technicians in a clear and structured manner.
• Ability to collaborate and communicate effectively with cross‑functional teams, including quality, engineering, and operations.
• Strong ability to manage multiple priorities and adjust to changing demands in a manufacturing environment.
• Ability to read, understand, and interpret Standard Operating Procedures (SOPs), work instructions, and other technical documentat