Senior Manufacturing Engineer

BALT Group • Irvine, CA

4d • Onsite

About The Position

This fast-paced position will be responsible for the transfer of neurovascular products. You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Requirements

• Bachelor’s Degree required, preferably in Engineering.
• Class II, IIB and III Implantable Medical Device Experience
• Typical experience required is a minimum of 4 years minimum as an Engineer in a related field.
• Deep process validation knowledge and medical device or pharmaceutical experience is required.
• Experience creating and implementing new production line layouts using lean methodologies.
• Demonstrated Equipment Qualification knowledge and execution
• Statistical analysis skill set is required
• SolidWorks experience required with demonstrated application to develop manufacturing equipment, fixturing and tools
• A demonstrated ability to plan and run projects is highly desired
• Able to travel internationally, especially to Europe
• Ability to prepare project plans, specifications, and schedules for personal and cross-functional projects related to manufacturing changes
• Knowledge and application of standard catheter, balloon, or implantable/stent devices manufacturing processes and equipment
• Ability to develop master validation plans to meet FDA and ISO requirements for class II and class III devices
• Knowledge to develop and improve manufacturing processes from concept to implementation including characterization, validation and cost/capacity analysis.
• Experience with design and process FMEA (risk management per ISO 14971) as well as translating the associated risk analysis to Process Validation and process control requirements
• Application of statistical and analytical methods for process development, optimization and control such as SPC, SQC, and DOE using six sigma principles
• Process background (development, capability, optimization, validation) within the medical device industry
• Development of manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders)
• Effectiveness with lab equipment, assembly tools and measurement devices
• Skills to perform routine analysis of test results in relation to design specifications and test objectives
• Application of lean and six sigma tools to analyze a production line and determine and implement improvements for efficiency and capacity
• Development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design) including characterization and definition of equipment functional requirements and system capabilities
• Proficiency in SolidWorks for both part and fixturing/equipment design
• Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required
• Equipment and tooling design and optimization using DFM and Six Sigma principles.
• Comfortable working independently and cross-functionally as part of a team
• Ability to handle ambiguity within tasks/direction and determine solutions for successful execution
• Effective interpersonal communication to peers, production personnel and management

Nice To Haves

• Neurovascular experience is a plus
• Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
• Minitab proficiency highly desired with clear understanding of six sigma applications for data visualization and analysis.

Responsibilities

• Daily work includes engineering support of existing products and processes as well as ongoing improvement activities and projects including cost and efficiency improvement, capacity increases and manufacturing line duplications between sites.
• Provide support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met, frequently using lean and six sigma techniques. This includes direct interaction with production operators for training, trouble shooting and collaboration.
• Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
• Address non-conformances and CAPAs with appropriate containment, investigation, scoping and planning of actions where appropriate based on root cause investigation.
• Interface with New Product Introduction, Quality and Research and Development organizations in design control projects to integrate new products or processes into the existing manufacturing area.
• Process development, validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a clear understanding of FDA’s QMSR and cGMP, ISO 13485 and a good understanding in the application of statistics to process analysis and improvement.
• Equipment development and design of fixturing and tooling in order to improve process reliability, repeatability and capability.
• Development of project plans and timelines using software such as MS Project and management of cross-functional projects to meet timelines and objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior