Environmental Health
3 weeks ago
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
Work Shift
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