Senior Engineer (Bengaluru)

Senior Engineer (Bengaluru)

23 Aug
|
Baxter India
|
Bengaluru

23 Aug

Baxter India

Bengaluru

As Compliance Engineer:
- Coordination and management of standards compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products.
- Partner with design engineers (Hardware, Mechanical, Software) to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, compliance and safety issues.
- Consult with program teams on product certification strategy and compliance issues where needed
- Facilitate and coordinate input from multiple cross-functional partners including Regulatory team, program management, R&D; teams, manufacturing sites and service locations to develop comprehensive product certification and compliance strategies,



and ensure that Baxter Healthcare solutions comply with product certification requirements in the intended use markets
- Keep abreast of changes to product standards and regulations affecting medical products.
- Ensure that all compliance test equipment complies with the test requirements specified in compliance standards.
- Schedule compliance testing for Baxter Healthcare products at onsite test facility and at external test laboratories. Manage product test and certification projects with onsite and external test laboratories.
- Prepare standards test reports and other documentation in accordance with applicable regulations.
- Submit documentation to regulatory authorities as required to obtain product certifications for different global regions (e.g. US, Canada, Europe, Korea, Japan, Australia/Recent Zealand, Latin America, Caribbean, MEA)
- Support the development System requirements and drive the cascade of the requirements to hardware and software subsystem re

📌 Senior Engineer (Bengaluru)
🏢 Baxter India
📍 Bengaluru

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