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