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.
- 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.
- Bachelor’s Degree in Mechanical or Electrical Engineering.
RELEVANT WORK EXPERIENCE:
- At least 5 years’ manufacturing and production experience with medical device or pharmaceutical manufacturing operations/equipment.
- Experience utilizing Lean and Six Sigma tools.
- Experience applying Risk Management practices and tools including PFMEA.
- Experience with equipment calibration.
- Experience working with high-speed automation equipment and programming, debugging, and maintenance of PLC systems (Allen Bradley, RS Logix) as well as touch panel interface systems (HMI design).
- Computer-Aided Drafting with solid modeling experience using Solids Works and AutoCAD.
- Job requires employee to stand, walk, talk, provide training to individuals or groups and do presentations for upper management.
- Job requires employee to spent at least 40% of work-time on the computer.
- Work environment: manufacturing floor; commonly work near machinery; office
- Noise level in the manufacturing work environment may become on occasions loud. Noise level in the office work environment is usually quiet.
- Willing to be available to support off-shift resources as necessary -- position is responsible for technical staff across multiple shifts on a 24 hour working schedule.
Relevant Work Experience
- At least 3 years’ experience in managing technical personnel and complex activities.
- Experience applying problem solving, project management and supervisory skills in a manufacturing environment.
- Experience with MiniTAB and Visio.
- Computer literate and proficient in: Microsoft Office – Outlook, Word, Excel and PowerPoint, and MS Project.
All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s). This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.
Code Of Federal Regulations