Position – Design Engineer
Company – Becton, Dickinson and Company
Location – Bengaluru, Karnataka
System Engineer will lead in the successful requirements generation, development, verification and validation of high-volume single use disposable medical products. The System 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
- Architect the development and maintenance of platform user needs and design input requirement
- Provide leadership to ensure that design output specifications, risk assessment documents, usability and V&V documentation, and other technical documentation meet design inputs.
- Lead and influence efforts to develop (and author) user needs and intended uses as well as other stakeholder need statements.
- Lead system decomposition of Design Inputs to design outputs including various specifications and drawings.
- Own and lead 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.
- A 4-year engineering degree in relevant field is required (i.e. Systems, Mechanical/Industrial & Production/Bio-medical/Chemical/Materials Engineering/ Instrumentation/)
- Minimum 2 years of experience as a Systems Engineer in regulated industry like medical device, aerospace, or department of defense with proven ability to influence and lead cross-functional teams.
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.