Responsible for manufacturing and process engineering functions. Ensure Production Managers and Supervisors receive the support they need from the engineering group in order to accomplish production goals.
Maintain manufacturing equipment and processes to ensure product meets required product performance requirements and associated specifications.
Ensure all products manufactured meet company established product specifications by enforcing internal procedures SOP’s, DMR’s and cGMP standards as required by the Quality Systems regulations – CFR 820 and ISO 13485:2003, CMDCAS and other regulations.
CORE JOB RESPONSIBILITIES:
- Work in coordination with plant operations and technical teams to ensure syringe and saline production does not interfere with other plant operations.
- Responsible for engineering projects planning, execution and completion within established time frames, meeting project objectives, and project cost targets.
- Determine and enforce quality and safety requirements in accordance with company needs, based on current regulations and product development. Work in conjunction with Safety, HR and facilities to ensure compliance with OSHA requirements.
- Oversee and provide daily support to the engineering group including Technicians and facilities support. Coordinate and/or provide training for the mechanics and engineering group.
- Establish and maintain SOPs for maintaining high standards of productivity, quality, reliability and safety in manufacturing, product designs and/or existing engineering applications.
- Participate in the design and development, as well as the continuous improvement of, the automated manufacturing equipment. Document and maintain validated equipment software. Procure and maintain equipment spare part inventories. Negotiate and maintain service contracts.
- Concentrate on equipment in order to improve area efficiencies and improve product quality. Maintain process efficiencies utilizing appropriate metrics to measure performance against stated goals.
- Identify, implement and qualify equipment, process, and/or product improvements to result in cost reductions or improved product quality. Evaluate and develop improved techniques for the control of product designs, testing, reliability and safety.
- Support Product Development and Regulatory affairs during new products design, testing and qualification/validation
- Control and ensure that critical spare parts and equipment support services are available to fulfill production schedule.
Job Type: Full-time
Pay: $85,000.00 - $100,000.00 per year
- Manufacturing Engineering: 4 years (Preferred)
- validation: 4 years (Preferred)