Design Engineer-II

• 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 defence.

• 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 of basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies & ability to analyse, organize and present large amounts of data in a clear and concise manner.
• Multiple end-to-end new product development and sustenance engineering experience

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

• Participated in voice of customer gathering, requirements management and risk management activities as part of product development.

• -Not Applicable-

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