Systems Engineer - Remote - confidential

    confidential
    confidential Remote

    7 hours ago

    Full time ₹1,800,000 - ₹4,000,000 (INR) per year *
    Description

    Roles and Responsibilities:

    • Lead the end-to-end system design of respiratory therapy devices, including hardware, firmware, and software integration.
    • Define system-level requirements and specifications in collaboration with cross-functional teams.
    • Evaluate the technical, regulatory, and safety implications of engineering and design change requests to ensure system integrity and compliance throughout the product lifecycle.
    • Identify and define Critical to Safety (CTS) and Critical to Quality (CTQ) parameters during design and development.
    • Support verification and validation (V&V) activities across system and subsystem levels.
    • Maintain and update traceability matrices for system requirements, risks, and testing.
    • Ensure adequate traceability from design inputs to verification outputs and risk mitigations.
    • Apply strong understanding of safety risk management, including:
    • DFMEA
    • Product risk analysis
    • Risk mitigations
    • Ensure compliance with ISO 14971 and other relevant risk management standards.
    • Demonstrated knowledge of global regulatory frameworks including:
    • FDA 21 CFR Part 820.30
    • ISO 13485
    • IEC 60601 series
    • ISO 14971
    • Maintain documentation for Design History File (DHF), traceability matrices, and risk files.
    • Experience with requirement management tools (e.g., IBM DOORS) and lifecycle management platforms (e.g., Windchill).
    • Collaborate with mechanical, electrical, software, quality, and regulatory teams throughout the product lifecycle.Lead and participate in design reviews, risk assessments, and Phase Gate Reviews.
    • Lead and participate in design reviews, risk assessments, and Phase Gate Reviews.

    Education & Skills preferred:

    • Degree preferred, MTech / BE/ BTECH in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or related field.
    • 3-5 years of experience in medical device product development, and overall 5-10 years of experience.
    • Experience with ventilators, CPAP, BiPAP, or similar life-support systems is highly preferred.
    • Basic understanding of system engineering principles and lifecycle.
    • Exposure to design controls and regulatory frameworks (e.g., FDA, ISO
    • Familiarity with risk management processes (e.g., ISO
    • Hands-on experience with testing, debugging, and documentation.
    • Knowledge of DOORS and Windchill would be added advantage.
    • Strong analytical and problem-solving skills.
    • Good written and verbal communication skills.
    * This salary range is an estimation made by beBee
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