Lead System Design/Product Development-Medical Device

Job Title: Lead System Design Engineer/ Product Development- Medical Device

Department: R&D

Location: Pune

Experience: 7+ years of experience in system design and architecture, with a proven track record in the development of medical devices

Reporting to:

Purpose of Function:

The Lead Systems Designer / System Architect is responsible for leading the design, development, and integration of medical devices. This role ensures the product meets customer and technical requirements while complying with regulatory standards and safety protocols. The Lead Designer manages system architecture, drives risk management processes, oversees system integration, and ensures seamless team collaboration. Additionally, the role includes overseeing engineering change management, ensuring changes are thoroughly reviewed, documented, and aligned with project goals, and ultimately delivering high-quality, reliable, and compliant medical systems.

Tasks and Responsibilities:

System Design & Architecture:

Develop a detailed plan for designing and developing systems and related activities, and follow-up for execution.

Attain project milestones and stage gates, ensuring on-time completion of deliverables within the project quality framework.

Requirements Management

Cross-functional Collaboration:

Risk Management:

System Integration & Testing:

Documentation & Reporting: Prepare comprehensive documentation for system designs, requirements, and integration plans. Regularly communicate progress and technical insights to management and cross-functional teams.

Regulatory Compliance:

Engineering Change Management and Issues/Defect Resolution via Defect Review Board: Identify and solve technical challenges, analyze root causes, and implement corrective actions.

Leadership & Ownership:

Provide support for organizational and departmental initiatives, including design transfer and localization efforts.

Qualifications & Experience

B.Tech/BE in Computer Engineering / Electrical & Electronics Engineering / Mechanical Engineering

Systems Engineering Expertise:

Risk Management:

Software Tools:

Collaborative Skills:

Regulatory Knowledge: