System Engineer - Design Verification Engineer

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). Application of fluid flow engineering principles and advanced engineering methods to gain deep understanding of the underlying technical issues in drug delivery.

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

Job Position Skill Set:

• 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 is preferred. 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