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Senior Design Engineer

4.00 to 0.00 Years   Bangalore   31 Mar, 2021
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaSales / BD,R&D / Product Design
EmploymentTypeFull-time

Job Description

Job Description SummarySystem 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. Job DescriptionSystem 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 4 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 of basic 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 LocationIND Bangalore - Technology Campus Additional LocationsWork Shift,

Keyskills :
autocadcaddrawingmodelingmechanicalsubject matter expertsverificationvalidationproduct designdesign historyrisk managementrisk assessmentregulated industry

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