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 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.
