Job Description

Summary System Engineer will lead in the successful requirements generation, development, verification and validation of high-volume single use disposable medical products. The System Engineer will learn and utilize BD's stage gate fr

Summary System Engineer will lead in the successful requirements generation, development, verification and validation of high-volume single use disposable medical products. The System Engineer will learn and utilize BD's stage gate framework (GPDS) Global Product Development System and use DFM/DFSS and relevant engineering tools to deliver a high quality, cost-effective designs and will partner Architect the development and maintenance of platform user needs and design input requirement Provide leadership to ensure that design output specifications, risk assessment documents, usability and V&V documentation, and other technical documentation meet design inputs. Lead and influence efforts to develop (and author) user needs and intended uses as well as other stakeholder need statements. Lead system decomposition of Design Inputs to design outputs including various specifications and drawings. Own and lead cross-functional technical meetings to vet design trade-offs and proposed solution. Advocates, conducts and participates in Technical Reviews. Develops and maintains System Architecture documentation, including interface diagram, functional diagram etc. Execute Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed. Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a Medication Delivery Solution (MDS) product. Work with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues. A 4-year engineering degree in relevant field is required (i.e. Systems, Mechanical/Industrial & Production/Bio-medical/Chemical/Materials Engineering/ Instrumentation/) Minimum 2 years of experience as a Systems Engineer in regulated industry like medical device, aerospace, or department of defense with proven ability to influence and lead cross-functional teams. Knowledge ofbasic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies & ability to analyze, organize and present large amounts of data in a clear and concise manner.Primary Work Location IND Bangalore - Technology CampusAdditional Locations Work Shift