Manufacturing Lead

Position Summary

The Manufacturing Lead is accountable for manufacturing GammaTile products efficiently, accurately, safely, and on time. This position provides daily direction and leadership to manufacturing technicians in their area of responsibility. This position also communicates effectively with their leadership the needs and capabilities of their area of responsibility. When needed, this position also operates manufacturing equipment and in-process instrumentation to manufacture regulated products in accordance with QSRs, company policy, applicable regulatory requirements, and safety regulations. Works on assignments that are routine in nature where the ability to recognize deviation from accepted practice is required. This position requires attention to detail and relies on instructions and pre-established guidelines to perform the functions of the job. The Manufacturing Lead identifies areas for improvement, uses good documentation practices and statistical techniques, and drives continuous improvement to the GammaTile platform. This position will mentor and coach Manufacturing Technicians.

Job Duties/Responsibilities

· Performs all work in compliance with company policy and within the guidelines of GT Medical Technology’s Quality system.

· Provides daily direction to team members of assigned area to ensure GammaTile products are manufactured on time according to all associated policies.

· Manufactures, assembles, and ships regulated products and sub-assemblies, including medical devices that are of radioactive nature.

· Operates production equipment within controlled environments.

· Maintains records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.

· Review timecards to ensure accuracy and compliance with company policies.

· Supports with training and progression of team members.

· Monitors and escalates employee relations issues.

· Lead team meetings.

· Hold check-ins/one-on-ones with team members.

· Relies on instructions and pre-established written guidelines to perform job functions.

· Maintains organization and cleanliness of all designated manufacturing areas.

· Assists with in-process testing to assure batches meet specifications.

· Identifies opportunities to improve processes, tooling and production equipment, assembly methods, materials, and parts.

· Assists with maintenance activities.

· Provides mentorship and coaching to Manufacturing Technicians.

· Embodies the Company’s purpose and shared values, building a positive and productive team culture.

· Complies with Company policies and procedures.

· Follows all safety rules and safety precautions.

· Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.

· Become an authorized user of one or more areas in the facility.

· Other duties as assigned.

Qualifications

• High School degree or equivalent, Associate’s degree in technical field preferred.
• Minimum 5 years manufacturing/operations experience including a minimum of 1-year medical device manufacturing preferred.
• Manufacturing experience and handling of radioactive materials in a radiation-controlled environment required.
• Ability to effectively communicate tasks and instructions from management to Manufacturing Technicians.
• Ability to operate and communicate effectively with cross-functional teams.
• Ability to manage multiple priorities.
• Ability to read and interpret Standard Operating Procedures (SOPs) and work instructions.
• Must be able to perform basic mathematical functions using whole numbers, fractions and decimals.
• Must be able to compute averages, rates, percent and to draw and interpret bar graphs.
• Excellent written and verbal communication skills.
• Proficient in using Microsoft office programs (Word, Excel, and PowerPoint).
• Willingness to work a flexible schedule.
• Able to travel for work as needed.
• Satisfactorily pass comprehensive background and drug screening.

Physical Demands/Working Conditions

• Works in office space, supply room, laboratory, and/or clean room environments.
• Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Requires frequent finite hand/eye coordination.
• Largely a stationary role with some moving from place to place.
• Frequent use of a computer, keyboard, mouse, monitor and other office equipment.
• Frequent use of laboratory and manufacturing equipment.
• Frequently picks up, carries, and moves items up to 50 lbs.
• Some evening and weekend work depending upon workload.
• Some overnight travel may be required for work, events, and training.