Associate Staff Design Engineer

Job Description

Job Description Summary

Role: Associate Staff Design Engineer

Location: Bangalore- India Organic Center.

The Associate Staff Design Engineer will lead 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.

A 4-year engineering degree in relevant field is required (i.e. Systems, Mechanical/Industrial & Production / Bio-medical / Chemical / Materials Engineering/ Instrumentation/)

Minimum 12 years of experience as a Design 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

• 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 12 years of experience as a Design 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.

Keyskills :
adcartcalibrationcmosdacsubject matter expertsverificationvalidationsupply chainproduct designprocess designdesign historyrisk managementrisk assessmenttechnical designregulated industrydevelopment designproduct developmentsystem archite