Manufacturing Engineer – On-site in Temecula, CA

The manufacturing engineer will have two primary functions: support and/or lead sustaining engineering projects for the department and support manufacturing operations in our client’s Vascular Division.

Day-to-Day Responsibilities

• Support manufacturing activities, keeping safety, quality, cost, and production in mind.
• Maintain systems that support the monitoring of key performance indicators such as yield, nonconforming material, or lead time. If indicators show an adverse trend, work with the functional team to plan and implement appropriate changes.
• Support the 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.
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Understand cause and effect of line and product/process changes.
• Understand 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.
• Maintain manufacturing documentation such as manufacturing process instructions, lot history records, bill of materials.
• Investigate, conduct tests or experiments, gather data, perform analysis, and report findings. Prepare and communicate recommendations and respective action plans.
• Lead root cause analysis efforts for basic/simple manufacturing events, utilizing DMAIC model and A3s.
• Support 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.
• Provide 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.
• Perform 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.
• Execute line-related change management (material, equipment and process changes).
• Change order “CO” and Change Request “CR” generation related to changes impacting the manufacturing line.

Qualifications

• 3 years in commercial manufacturing, preferably in the medical device industry
• BS degree in Engineering or equivalent
• 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
• Familiar with CO/CR process
• Six Sigma

Term & Start

• 6.5-month contract, starting 6/10/24
• On-site in Temecula, CA (92591)
• Pay Rate: Up to $47.50/hr ($95k annually)
• FT hours, M-F 7a-3:30p; may require flexibility to work with teams in EST time zones
• Business Unit: Vascular