Balt · 1 month ago
Engineering Manager - Operations
Irvine, California, United States
Full-time
Onsite
Mid, Senior Level
$150K/yr - $170K/yr
5+ years expBalt is a rapidly growing pioneer in the medical device industry, focused on improving patient lives. The Engineering Manager, Operations will lead a team of Manufacturing Engineers and Technicians to enhance manufacturing processes and ensure the successful integration of new products into the production environment.
Health CareManufacturingMedical Device
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
Qualification
Required
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
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)
Proficiency in SolidWorks
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
Preferred
Neurovascular experience is a plus
Strong background in metals, plastics, extrusion, and/or adhesives is highly desired
SolidWorks and Minitab proficiency are highly desired
Microsoft Project and Microsoft Visio proficiency are highly desired
Company
Balt
Balt is specialist manufacturer of 'Interventional Neuro Radiology’ (‘INR’) devices used to treat strokes and aneurysms
501-1000 employees
H1B Sponsorship
Balt has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
Funding
Current Stage
Late StageTotal Funding
$370.32M2024-12-20Debt Financing· $370.32M
2015-09-25Private Equity
2015-09-25Acquired
Leadership Team
Pascal Girin
CEO
Emeric Domergue
Deputy CFO
Company data provided by crunchbase