System Engineer

" 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 :

o DFMEA

o Product risk analysis

o Risk mitigations

Ensure compliance with ISO 14971 and other relevant risk management standards.

Demonstrated knowledge of global regulatory frameworks including :

o FDA 21 CFR Part 820.30

o ISO 13485

o IEC 60601 series

o 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 13485).

Familiarity with risk management processes (e.g., ISO 14971).

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.

FYI 5yrs B / R-11 LPA