Role & 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 robust understanding of safety risk management, including: o DFMEAo Product risk analysiso 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 820.30o ISO 13485o IEC 60601 serieso 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 ventilator

📌 MNC Co. Looking For system design/ Hardware Engineer Pune
🏢 Staffing Services
📍 Pune