Title:  Manufacturing Assembly Technician I

Location: Onsite

Status Type: Full Time

Shift: 2nd Shift (M-F 2:00PM-10:30PM EST) 

QUALIFICATIONS

Required:

• Position requires High School diploma or GED
• Ability to read and write fluently in English
• Must be a detail-oriented individual who is highly organized and willing to work in a constantly evolving environment
• Must have excellent interpersonal skills and be able to consistently demonstrate a high degree of professional maturity
• Ability to maintain regular attendance and punctuality requirements
• Willingness and ability to work overtime as needed on both weekdays and weekends
• Must be able to work independently as well as collaboratively with team members as needed

Preferred:

• Experience working in a regulated FDA, or other government agency, environment
• Prior experience with GMPs and/or SOPs

Skills & Competencies:

• Basic computer skills (Outlook, web browsers)
• Ability to read and understand all company procedures and policies
• Ability to perform basic arithmetic
• Ability to take direction from supervisors and collectively work with others in a team environment
• Ability to work in a constantly changing, dynamic work environment.
• Required to work in a Clean Room (ISO Class 8 or higher) during the entire shift and maintain high standards of personal hygiene
• Ability to follow Good Documentation Practices to complete documentation in English as needed to record work or inspection data
• Ability to work as an individual in a team environment where all Technicians are responsible for the quality of finished devices
• Excellent time management
• Must be able to perform cleaning duties as assigned
• Remain current in online training as required

Physical Requirements:

• Ability to work with small parts, using hands , tweezers, magnification or other visual aids
• Working in an environment with repetitive motion during the execution of assembly tasks for extended periods of time
• Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time
• Ability to read and comprehend Quality System Procedures, Operating Procedures, and Inspection Requirements, and demonstrate the execution of tasks to meet Enable Injections Quality System requirements
• Ability to operate mechanical machinery and inspection equipment
• Ability to sit and stand for an extended period
• Ability to perform visual inspection during device assembly and disposition appropriately
• Position requires being physically present on the premises during regular company hours or as approved by management 

RESPONSIBILITIES:

• Assembly and packaging of medical products in accordance with documented procedures
• Maintaining a high level of quality in the execution of all tasks
• Assisting manufacturing and quality assurance with the formal and informal inspection of components, subassemblies, and finished devices while executing tasks
• Adherence to Controlled Environment practices. 
• Performing general cleaning activities for Controlled Environment in accordance with established procedures
• Understanding and executing the Enable Injections Quality Policy and training requirements as they pertain to this job description
• Assisting production management with other manufacturing related activities which include organizing materials, loading boxes, counting and recording materials, completing documentation
• Other tasks as required by production management, including but not limited to: assembly of tables and other furniture or equipment for manufacturing purposes, cleaning of surrounding manufacturing areas including the warehouse and hallways, etc.