Title:  Manufacturing Assembly Technician III

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
• Three 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 independently as well as working 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 weekend

Preferred:

• 3-5 years prior experience in the Medical Device or Pharmaceutical industry
• Experience working in a regulated FDA, or other government agency, environment
• Experience providing hands-on training to less experienced MATs
• Prior experience with GMPs and/or sanitation SOPs

Skills & Competencies:

• Basic computer skills (Outlook, web browsers)
• Ability and willingness to help train and develop Level I and Level II Manufacturing Technicians in a positive and productive manner
• 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
• Able to work with little to no supervision
• Work independently as well as collaboratively with team members as needed
• 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
• Perform ERP transactions utilizing SAP maintaining accurate inventory movements and counts

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:

• Collaborate on the continuous improvement of assembly methods with Manufacturing Engineering and Product Development
• 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