Manufacturing Engineer II
26531 Ynez Road Rancho California, CA 92591 US
Job Description
Job description:
The manufacturing engineer will have two primary functions. The engineer will be responsible to support and/or lead sustaining engineering projects for the department. The engineer will serve as primary manufacturing engineer supporting operations in Vascular Temecula.
• Responsible for the daily support to the manufacturing activities in order to meet established goals for safety, quality, cost, and production.
• Maintains systems that support the monitoring of key performance indicators such as yield, nonconforming material or lead time. If indicators show an adverse trend, works with the functional team to plan and implement appropriate changes.
• Works with line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and support generation of ER, if needed.
• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
• Responsible for product/process knowledge and understanding of cause and effect of line and process changes.
• Understands potential risk related to product nonconformance. Has knowledge and expertise on product requirements and specifications.
• Has clear criteria of conforming/ non conforming product and the on-line and reliability test methods used for verifying product conformance.
• Maintains manufacturing documentation such as manufacturing process instructions, lot history records, bill of materials.
• Investigates, conducts test or experiments, gathers data, performs analysis, and reports findings. Prepares and communicates recommendations and respective action plans.
• Leads root cause analysis efforts for basic/simple manufacturing events, utilizing DMAIC model and A3s. Supports CAPA (Major) investigations with data gathering and analysis as needed.
• Line support representative for related projects such as yield improvements, Cost Improvement Project “CIP's”, productivity, quality and safety. Responsible for providing the line with related Engineering solutions, such as tooling (TLTs) and Manufacturing Aids ( from idea definition to implementation).
• Responsible for continuous improvement projects development and execution.
• Performs validation activities for new or existent production lines, meeting regulatory requirements. This includes equipment, process, product, test method validations, SCNs, equipment/material obsolescence, GMI initiatives
• Responsible for execution of line-related change management (material, equipment and process changes). Responsible for change order “CO” and Change Request “CR” generation related to changes impacting the manufacturing line.
Requirements:
- Min experience: 3 years in commercial manufacturing. Preferably in medical device industry
- BS degree engineering or equivalent
- Experience is using MS office applications
- Experience in line support, Quality systems, CAPA
- Experience in process qualification/validation
- Experience in problem solving using DMAIC or other methodologies
- Experience in Project management
- English proficient
Plus:
- Familiar with CO/CR process
- Familiar with internal systems (LHR, viewpoint, sumtotal, blueprint, others)
- Six sigma training
Must be motivated, self starter, organized, and can multitask.
Must have good communication skills (verbal and written)
There is no traveling.
Will require some flexibility on hours (to be aligned with production schedule and line support ME hours)
Will require to stand for extended periods of time (while in the clean room)
Pay Rate Range: $35-45/hr. Salary will be commensurate with experience
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