System Engineer - Design Verification Engineer

Overview

Keywords : Prefilled Syringe, Drug Delivery Systems, Infusion Pump, Test Method Development, Design Verification

Responsibilities

• Define, plan and lead activities for test method & measurement system development and validation and testing optimization in support of Design Verification.
• Creation and execution of verification protocols, summarize results, enable formal design reviews, and own the verification portion of the Design History File.
• Demonstrate proficiency in spotting Design Variance through relevant statistical measures.
• Application of fluid flow engineering principles and advanced engineering methods to gain deep understanding of the underlying technical issues in drug delivery.
• Collaborate with cross-functional teams to ensure product requirements are verifiable and measurable.
• Responsible for Complete end to end maintenance of test equipment validation and management of Test method validation records.
• Coordinate the sample Material Shipment & Vendor management
• Expertise with Design verification & validation strategy development and execution of Drug Device Combination Product is required.
• Expertise with DV Test method development, validation strategy, and execution for drug delivery systems such as Prefilled Syringes, Autoinjectors, On Body injectors, Infusion pumps etc.,
• Exposure in fixture design & 3D Printing (SolidWorks preferred)
• Strong knowledge in DHF / Design control process and familiarity with any Document Management System
• Proficiency in fluid mechanics / mechanics of materials and proficiency statistical methods / tools is required.
• Experience with design standard methodologies, including advanced tolerance design, and design for reliability
• Experience and Knowledge on Medical Devices Regulatory Standards
• Experience using Zwick and flow measurement equipment ispreferred. Familiarity with 3D printing, CT Scanners, Viscometers, Climate Chambers, etc. is a plus.
• Experience in solid modeling (SolidWorks) or electromechanical systems is a plus.
• Experience developing and commercializing medical devices is a plus

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