Manufacturing Technician, Clean and Pack

restor3d•Durham, NC

10h

About The Position

The Manufacturing Technician operates production equipment productively while maintaining a high level of quality in the manufacture of restor3d implants and components. The role supports the Manufacturing department’s objectives and works with colleagues across restor3d. Duties include equipment start-up and maintenance, machine setup and operation, component inspection and assembly, cleaning, pouching, sealing, and labeling. The technician also maintains accurate production and ERP records, supports inventory activities and corrective-action investigations, reviews manufacturing documentation, and helps keep manufacturing areas clean and safe. The position requires compliance with company policies, safety requirements, Standard Operating Procedures, Work Instructions, Good Documentation Practices, Good Manufacturing Practices, and applicable regulatory standards.

Requirements

High school diploma, GED, or equivalent work experience.
Familiarity with Oracle or equivalent ERP systems and Microsoft Office applications.
Familiarity with ISO standards and Good Manufacturing Practices.
Good written and verbal communication skills, including demonstrated English reading and writing skills.
Ability to monitor one’s own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Ability to self-motivate and work independently as well as as part of a team.
Manual dexterity to handle tools, inspection gauges, and equipment of different sizes.
Ability to work in a fast-paced environment and multitask.
Comfort with change.
Ability to lift, pull, and push up to 40 lbs.
Ability to stand for prolonged periods.
Ability to work for prolonged periods in a Class 10,000 or ISO Class VII clean room environment.
Flexibility to work overtime, extended hours, and weekends as business demands.
Ability to work in changing environments, including reduced lighting, increased noise, temperature variances, unpleasant odors, and dust.
Awareness of company hazards and adherence to quality and safety standards established by the FDA and other regulatory agencies.

Nice To Haves

Work experience in a medical device and/or regulated environment.
Shipping, receiving, or stockroom experience.

Responsibilities

Develop and maintain strong internal working relationships across restor3d.
Understand and work toward the objectives, responsibilities, and mission of the Manufacturing department.
Prioritize and plan work activities, adapting to changing conditions.
Execute daily maintenance and start-up activities.
Perform machine set-ups.
Operate machinery and processing equipment, including clean lines and pouch sealers.
Inspect components and perform assembly as required.
Perform cleaning, pouching, sealing, and labeling.
Follow Good Documentation Practices when executing assignments.
Complete timely and accurate workflow transactions in the ERP system.
Participate in inventory cycle counts, variance investigations, and reconciliation.
Assist in investigating product and process failures and implementing corrective actions.
Comply with company policies and procedures, including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
Maintain manufacturing areas and provide a clean and safe work environment.
Review manufacturing documentation and assembly, inspection, test, and packaging procedures, and provide feedback.
Perform other duties as assigned.