System Engineer

1 week ago

Pune, India foundit Full time
Key Job Responsibilities:
- Manage and maintain system-level requirements using systems engineering principles and requirements management tools.
- Understand and decompose technical system requirements into detailed subsystem/unit requirements.
- Contribute to and review software and hardware systems architecture.
- Write and review technical system requirements with cross-functional teams; update and maintain these in DOORS.
- Drive traceability from technical system requirements to technical subsystem requirements and associated risk files.
- Apply knowledge of ISO 14971 to drive the risk management process for medical devices.
- Identify applicable regulatory standards and ensure documentation meets compliance needs.
- Possess foundational understanding of electronics, electrical, mechanical, and software design concepts.
- Contribute to system-level DFMEA and cascade findings to subsystem-level FMEA.
- Perform verification and validation of medical devices at the system level, including test case creation, reviews, and execution.
- Prepare high-quality documentation for regulatory submissions.
- Support and understand system integration planning, testing, and reporting.
- Coordinate with external testing labs to ensure compliance with required standards and certifications.
- Work collaboratively with cross-functional engineering and quality teams to ensure project success.
- Maintain clear and effective documentation and reporting throughout the development lifecycle.
Preferred Behavioral Skills:
- Agility: Drive fast and effective decision-making and actions
- Confidence to take on the world: Think big and embrace challenges
- Transparency: Build trust by sharing information openly
- Improve Collaboration: Foster teamwork to drive collective success
- Ownership: Take responsibility and deliver results effectively
- Nurture Learning & Growth: Support the continuous development of team capabilities

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