Title:  Manufacturing Assembly Technician II

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
• One or more years of manufacturing experience is required, following written instructions within a regulated environment
• 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 adaptable interpersonal skills and ability to work well with others in a team setting
• 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:

• 1-3 years prior experience in the Medical Device or Pharmaceutical industry
• Experience working in a regulated FDA, or other government agency, environment
• Prior experience with GMPs and/or sanitation 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) for 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
• Ability and willingness to help train and develop Level I Manufacturing Technicians in a positive and productive manner
• Excellent time management
• Must be able to perform cleaning duties as assigned
• Remain current in online training as required
• Ability to become a subject matter expert and to coach less experienced MATs on processes

Physical Requirements:

• Ability to work with small parts, using magnification or other visual aids
• Working in an environment with repetitive motion during the execution of assembly tasks
• 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 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