Environmental Health

3 weeks ago

Canaan, United States BD (Becton, Dickinson and Company) Full time

Job Description Summary

Job Description

Position Summary

The Design Engineer II 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 System 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.

Educational Background

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

Professional Experience

* Minimum 3 years of experience in end-to-end product development, scope of product development ranging from user needs gathering to Design transfer to manufacturing
* Minimum 2 years of experience as a Systems Engineer/ equivalent role in regulated industry like medical device, aerospace, or department of defense.

Job Responsibilities

* Contribute towards the development and maintenance of user needs and design input requirements.
* Key contributor 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 decomposing of (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.

Knowledge and Skills

Knowledge

* 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.
* Multiple end-to-end new product development and sustenance engineering experience

Skills

* Disciplined and well organized in documentation in a regulated environment.
* Ability to execute concurrently multiple projects and manage priorities.
* Strong Verbal & Written communication skills.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

* Led/Participated/Designed in voice of customer gathering, requirements management and risk management activities as part of product development.

Any additional Information (Specially if needed for Quality or legal purposes)

* -Not Applicable-

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

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