Job Summary:
In this role, you will be responsible for maintaining operation efficiency of automated assembly lines. Provide support to shift operations as request by the shift leader/production manager. You must also develop long-term predictive/preventative maintenance plans for all assembly equipment.
Essential Duties and Responsibilities:
- Logically troubleshoots and repairs the pilot assembly line and related bench top equipment.
- Assists shift lead in maintaining quality of finished product through proper machine operation.
- Responsible for maintaining spare parts inventory with a proper cataloging of parts.
- Provide a timely notification to shift lead of maintenance issues and downtime.
- Reviews line history and documentation to enhance line efficiencies. Follows escalation plan to minimize downtime.
- Maintains and updates all equipment log books with accurate repair/adjustment information.
- Interfaces daily with shift leader and technician at shift change.
- Maintains cleanliness of all equipment.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
Basic Qualifications:
- Education or Equivalent Experience: 2-year technical degree.
- 2 years of experience in related industry.
Preferred Knowledge, Skills and Abilities:
- Experience in medical device industry or other regulated industry.
- Background with medical/pharmaceutical clinical trials would be a plus.
- Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and ISO 9002.
Travel Requirements:
Physical and Mental Requirements:
- Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
- Medical Device manufacturing requires strict adherence to standards . Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics . Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may always be stressful due to competing resources while maintaining company confidentiality.