MNC Co. Looking For system design/ Hardware Engineer Pune

Staffing Services; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Staffing Services in Pune, India, seeks an experienced engineer to lead the end-to-end system design of respiratory therapy devices, integrating hardware, firmware and software with cross‑functional teams. You will define system requirements, evaluate regulatory and safety implications of design changes, and maintain traceability from design inputs to verification outputs and risk mitigating documents.

The role requires DFMEA, CTS/CTQ definitions, V&V support, and compliance with ISO 14971, ISO

Qualifications

• 3-5 years in medical device product development.
• Overall 5-10 years of engineering experience.
• Experience with ventilator devices.

Responsibilities

• Lead end-to-end system design of respiratory therapy devices.
• Define system-level requirements with cross-functional teams.
• Evaluate regulatory, safety implications of design changes to ensure system integrity.
• Identify CTS and CTQ parameters during design and development.
• Support verification and validation activities across system and subsystem levels.
• Maintain traceability matrices for system requirements, risks, and testing.
• Ensure traceability from design inputs to verification outputs and risk mitigations.
• Apply strong understanding of safety risk management, including DFMEA and risk mitigations.
• Ensure compliance with ISO 14971 and other risk management standards.
• Demonstrate knowledge of global regulatory frameworks including FDA 21 CFR Part 820.30, ISO 13485, IEC 60601 series, ISO 14971.
• Maintain DHF, traceability matrices, and risk files.
• Experience with requirement management tools (e.g., IBM DOORS) and lifecycle platforms (e.g., Windchill).
• Collaborate with mechanical, electrical, software, quality, and regulatory teams; lead and participate in design reviews, risk assessments, and Phase Gate Reviews.

Skills

System design

Regulatory compliance

V&V planning

Traceability

Risk management

Requirements management

Design reviews

Cross-functional collaboration

Quality systems

Education

MTech / BE/ BTECH in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or related field

Tools

IBM DOORS

Windchill

Job description

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 strong 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