Engineering Manager - Operations

BALT Group • Irvine, CA

2d • $150,000 - $170,000

About The Position

This fast-paced position will be primarily responsible for the management of manufacturing engineers. 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

• Four-year technical degree required(Bachelor’s), preferably in Engineering.
• Class II, IIb, or III Medical Device Experience
• 5 years minimum as an Engineer or engineering leader in a related field with at least 1 year being in a leadership/management role.
• Deep process validation knowledge in medical device or pharmaceutical experience is required.
• Equipment Development and Qualification experience
• Working knowledge of statistical analysis of various data types for the purpose of validation and process control/monitoring
• Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
• Experience creating, reading, interpreting and updating technical drawings for tooling/fixturing/equipment as well as part/product applications
• Ability to train and manage engineers and technicians in various procedures and skillsets needed to maintain and improve commercial manufacturing
• Directing engineers who lead project teams tasked with manufacturing improvement projects, manufacturing transfers as well as successful transfers into manufacturing.
• Ability to prepare project plans, budgets, specifications, and schedules for engineering resources and projects.
• Experience with catheters, balloons, or stents device manufacturing processes and equipment.
• Project Management using MS Project or similar tool
• Knowledge of DFM analysis and techniques to partner with development teams to bring products from pilot manufacturing into commercial manufacturing.
• Experience with process FMEA as well as Process Development, Process Characterization and Process Validation.
• Application of statistical and analytical methods such as SPC, SQC, and DOE.
• Use of root cause analysis tools and techniques too address problems (NCMRs/CAPAs) or identify potential opportunities.
• Process background (development, capability, optimization, validation) within the medical device industry including Lean and Six Sigma toolsets to analyze and improve production lines and processes.
• Development of manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders).
• Effectiveness with lab equipment, assembly tools and measurement devices
• Ability to perform routine analysis of test results in relation to design specifications and test objectives.
• Characterize and define equipment functional requirements and system capabilities.
• Development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design).
• Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.
• Ability to create presentations and effectively communicate relevant information to various levels of individual contributors and management.
• Comfortable working independently and cross-functionally as part of a team
• Experience designing manufacturing line layouts using Lean methodologies

Nice To Haves

• Neurovascular experience is a plus
• SolidWorks and Minitab proficiency are highly desired.
• Microsoft Project and Microsoft Visio proficiency are highly desired.
• Proficiency in SolidWorks.

Responsibilities

• Lead a team of Manufacturing Engineers and Technicians in supporting the ongoing manufacturing of commercial products as well as ensuring flawless integration of new products into the manufacturing environment.
• Daily work includes leadership and execution in both sustaining and project work –complete the types of projects that remove the need for engineering intervention– improving safety, quality, output and cost.
• 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.
• Further, improve systems to 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.
• Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
• Process validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA’s QSR and cGMP and a good understanding in statistics.
• Creation and maintenance of models for product cost and capacity to help prioritize engineering and production resources related to improvement projects.

What This Job Offers

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