BD is Hiring | Lead Design Engineer |

Position – Lead Design Engineer
Company – BD
Location – Bengaluru, Karnataka, IN

Job description

LEAD DESIGN ENGINEER – The Lead Systems Engineer will assist in the successful requirements generation, development, verification and validation of high-volume single use disposable medical products. You will have to 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.

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.
• Contribute to decompose needs statements into technical design input requirements.
• Conducts cross-functional technical review meetings to vet design trade-offs and proposed solution.
• Develops and maintains System Architecture documentation, including interface diagram, functional diagram etc.
• Execute Risk Management activities that ensures design and process shortcomings are 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 to emerging issues in production, quality, engineering, or supply chain proactively.
• Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.

Skills and Requirement

• Bachelor’s degree in relevant field is required (i.e. Systems, Mechanical/Industrial & Production/Bio-medical/Chemical/Materials Engineering/ Instrumentation/)
• Minimum 4 years of experience as a Systems Engineer in regulated industry like medical device, aerospace, or department of defence.
• Knowledge of basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies & ability to analyse & organize data clearly.
• Disciplined and well organized approach in documentation
• Ability to execute concurrently multiple projects and manage priorities.
• Strong Verbal & Written communication skills.

Note: Generic JD is used!