Perform the duties of a senior Manufacturing Engineer in the Albuquerque Packaging Workcell.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Learn medical device packaging processes/equipment and quality requirements to the SME level.
- Lead projects focused on selecting, installing, and validating new packaging equipment and processes.
- Lead efforts to optimize existing packaging equipment and processes.
- Assist the Workcell Manager and Lead Engineer to ensure coverage of Manufacturing Engineering responsibilities in the event of absences due to vacation, illness, training, or other reasons. Perform those duties if and when a critical need arises.
- Provide training and mentoring to less experienced Manufacturing Engineering staff on their assigned lines in subjects such as quality, equipment maintenance and repair, machine programming, and optimization.
- Interface with Production staff and other Manufacturing Engineers to determine corrective actions needed to optimize machine efficiency and operational effectiveness.
- Interact with Plant Management, Operations, Quality, Sterilization, and Purchasing to understand requirements, communicate status, and resolve issues.
- Create equipment and process documents and implement procedures that ensure operational excellence and design for manufacturing (DFM) principles are followed.
- Write and execute validation documents (IQ, OQ, SQ, PQ, PV) compliant with Jabil procedures and regulatory requirements.
- May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS and KNOWLEDGE REQUIREMENTS
- Manufacturing Equipment Lifecycle Management in a 21 CFR Part 820 environment
- Medical device packaging and terminal sterilization concepts
- Automated electromechanical systems with hands-on troubleshooting skills
- Networked equipment and SCADA, CMMS, and MES systems
- Selecting, commissioning, and validating automated manufacturing equipment
- Technical writing in a regulated environment
- Advanced PC and communications skills
Education & Experience Requirements
- Technical degree: Electrical/Mechanical/Chemical Engineering preferred
- 8+ years of experience with hi-volume manufacturing processes and equipment
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