08 Nov
|
CR Bard
|
Bengaluru
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Lead design verification activities, including development of verification strategies, protocols, test plans, and reports.
Develop, complete, and optimize product performance, reliability, and safety testing specific to healthcare equipment.
Analyze verification data using appropriate statistical methods and provide data-driven recommendations.
Investigate defects, failures, and design variances using structured root cause analysis techniques.
Interpret verification results and assess product performance, robustness, and manufacturing stability.
Collaborate with Systems Engineering, R&D;, Quality, Regulatory, Manufacturing, Marketing and Operations teams.
Maintain Design History File (DHF) documentation and ensure compliance with Design Controls and Quality Management System requirements.
Strong experience in Medical Device Verification & Validation (V&V;) .
Knowledge of Design Controls,
Risk Management, and regulatory requirements for medical devices.
Hands-on experience with statistical analysis, DOE, MSA/Gage R&R;, and data interpretation.
Experience translating product requirements into verifiable test methods and acceptance criteria.
Working knowledge of Power BI or equivalent data visualization tools.
Experience with CAD models, engineering drawings, and verification documentation is preferred.
Experience supporting products in US and European regulatory markets.
Knowledge of ISO 14971, ISO 13485 Design Control requirements, and medical device quality systems.
Experience leading verification workstreams in recent product development or sustaining engineering projects.
We welcome people with the imagination and drive to help us reinvent the future of healthcare. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Work Shift
📌 Senior Engineer, Product Design Engineering (Bengaluru)
🏢 CR Bard
📍 Bengaluru