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Job Description Summary
Role: Lead Design Engineer [1 role - MDS]

Location: Bangalore- India Organic Center.

Job Family: Research & Development

Supervisor: TBD

The Lead Design Engineer will assist in the successful requirements generation, development, verification and validation of high-volume single use disposable medical products. The Design Engineer will learn and utilize BD's stage gate framework (GPDS) Global Product Development Design and use DFM/DFSS and relevant engineering tools to deliver a high quality, cost-effective designs and will partner with a cross-functional team to design-transfer successful designs into manufacturing.

Responsibilities:
. Lead the development and maintenance of user needs and design input requirements.
. Key stakeholder in ensuring design output specifications, risk assessment documents, usability and V&V documentation, and other technical documentation meet design inputs.
. Participate in efforts to develop (and author) user needs and intended uses as well as other stakeholder need statements.
. Contribute to decompose (and author) needs statements into technical design input requirements.
. Conducts 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.
. Provide technical leadership for product design, development, integration, testing, and reliability improvements.
. Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
. Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.
Qualification:
. 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.
. 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.
. Disciplined and well organized in documentation in a regulated environment.
. Ability to execute concurrently multiple projects and manage priorities.
. Strong Verbal & Written communication skills.Job Description

Role: Lead Design Engineer [1 role - MDS]
Location: Bangalore- India Organic Center.
Job Family: Research & Development
Supervisor: TBD
The Lead Design Engineer will assist in the successful requirements generation, development, verification and validation of high-volume single use disposable medical products. The Design Engineer will learn and utilize BD's stage gate framework (GPDS) Global Product Development Design and use DFM/DFSS and relevant engineering tools to deliver a high quality, cost-effective designs and will partner with a cross-functional team to design-transfer successful designs into manufacturing.
Responsibilities:

• Lead the development and maintenance of user needs and design input requirements.
• Key stakeholder in ensuring design output specifications, risk assessment documents, usability and V&V documentation, and other technical documentation meet design inputs.
• Participate in efforts to develop (and author) user needs and intended uses as well as other stakeholder need statements.
• Contribute to decompose (and author) needs statements into technical design input requirements.
• Conducts 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.
• Provide technical leadership for product design, development, integration, testing, and reliability improvements.
• Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
• Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.
  Qualification:
• 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.
• 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.
• Disciplined and well organized in documentation in a regulated environment.
• Ability to execute concurrently multiple projects and manage priorities.
• Strong Verbal & Written communication skills.

Primary Work Location
IND Bangalore Technology CampusAdditional Locations
Work Shift