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2 days ago
As a Systems Engineer, you will work with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT.
The Medical Device and Healthcare practice is ISO 13485 certified.
- This role requires proficiency in systems engineering and requirements management.
- You should understand Technical System Requirements well and effectively flow them down into detailed Subsystem/Unit requirements.
- A good understanding of software and hardware systems architecture is necessary.
Key responsibilities include writing technical system requirements, reviewing them with a cross-functional team, and updating them in Doors (Requirement Management Tool). You will also drive traceability between TSR to TSSR's and Risk files.
Familiarity with ISO 14971, risk management process, and regulatory standards is required. Basic or expert knowledge of electronics, electrical, mechanical, and SW design is also necessary.
BenefitsYou will verify medical devices at the system level, including test case writing, review, and execution. Additionally, you will prepare documentation for regulatory submissions, ensuring compliance with applicable medical device regulations.
OthersExcellent documentation and reporting skills are essential for this role. You must be able to work collaboratively with cross-functional teams and coordinate with external test labs for testing of applicable standards/requirements.
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