Senior Process Engineer

BALT Group•Irvine, CA

2d•Onsite

About The Position

On behalf of a surgical and medical instrument manufacturing company with an emphasis on R&D, marketing, quality, sales, clinical affairs, and regulatory compliance, is responsible for supporting and continuously improving upon current manufacturing processes for the manufacture of neurovascular medical devices that save patient lives. Is responsible for technical and process innovation for the transfer of neurovascular products which diagnose and treat abnormalities of the blood vessels within or supplying blood to the brain and spine. Specific responsibilities will include: Design transfer and commercialization of new products, site manufacturing transfers, and the support of existing products and processes. Provide support to the Manufacturing organization to facilitate efficient operations within the production area, optimize existing processes, and ensure that production goals are met, especially pertaining to the introduction and transfer of new products into manufacturing. Monitor the performance of equipment, machines, and tools. Investigate and correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues. Characterize and define equipment functional requirements and system capabilities. Interface with Quality and R&D organizations in design control projects to integrate new products or processes into the existing manufacturing area. Perform process development, validation, and verification work, including applying knowledge of Factory Acceptance Test (FAT), Process Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), software validation, test method validation, Gage Repeatability and Reproducibility (R&R), and the U.S. Food and Drug Administration (FDA) Quality System Regulation (QSR) and Current Good Manufacturing Practice (cGMP) regulations. Initiate, design, and execute experiments to characterize process variation and control. Develop and test models of alternate designs and processing methods to assess feasibility, sustainability, operating condition effects, potential new applications, and necessity of modification. Develop project plans and timelines using project management methods and software including MS Project. Apply statistical and analytical methods for process development, optimization, and control including Statistical Process Control (SPC), Statistical Quality Control (SQC), and Design of Experiments (DOE). Develop manufacturing documentation including manufacturing procedures, engineering drawings, bill of materials (explaining the components required to manufacture the finished product), and work orders. Analyze test results in relation to design specifications and test objectives.

Requirements

Master’s degree in Mechanical Engineering, Biomedical Engineering, or a closely related technical field and 4 years of experience working in a process occupation within the medical device industry with Class III or Class II implantable medical devices.
Technical background in Process development and manufacturing.
Technical background in Medical device catheters, balloons, and/or implant coil device manufacturing processes and equipment.
Technical background in Class II or III medical device manufacturing.
Technical background in Fixture design and development.
Technical background in Polymer extrusion, reflow, thermal bonding, adhesive bonding, laser welding, braiding, and winding.
Proficiency using engineering software and tools including SolidWorks, MiniTab, Microsoft project, and Smartsheet.
Track record successfully transferring projects to manufacturing and meeting time-bound objectives.
Knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation, and gage R&R.
Thorough understanding of FDA’s QSR and cGMP.
Solid understanding of LEAN manufacturing and Green Belt certification in six Sigma.
Demonstrated leadership problem solving skills in A3, DMAIC, and DOE.
Excellent analytical, project planning, and execution skills with meticulous attention to detail.
Excellent communication, social, and presentation skills and leadership and self-starter qualities.
Background in Statistics, specifically in statistical and analytical methods including SPC, SQC, and DOE.

Responsibilities

Support and continuously improve upon current manufacturing processes for the manufacture of neurovascular medical devices.
Provide technical and process innovation for the transfer of neurovascular products.
Manage design transfer and commercialization of new products, site manufacturing transfers, and support of existing products and processes.
Support the Manufacturing organization to facilitate efficient operations, optimize existing processes, and ensure production goals are met, especially for new product introduction and transfer.
Monitor the performance of equipment, machines, and tools.
Investigate and correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues.
Characterize and define equipment functional requirements and system capabilities.
Interface with Quality and R&D organizations in design control projects to integrate new products or processes into the existing manufacturing area.
Perform process development, validation, and verification work, including applying knowledge of FAT, Process Validation Plans, IQ, OQ, PQ, software validation, test method validation, Gage R&R, and FDA QSR and cGMP regulations.
Initiate, design, and execute experiments to characterize process variation and control.
Develop and test models of alternate designs and processing methods to assess feasibility, sustainability, operating condition effects, potential new applications, and necessity of modification.
Develop project plans and timelines using project management methods and software including MS Project.
Apply statistical and analytical methods for process development, optimization, and control including SPC, SQC, and DOE.
Develop manufacturing documentation including manufacturing procedures, engineering drawings, bill of materials, and work orders.
Analyze test results in relation to design specifications and test objectives.