Job Description System Engineer
Location: Hyderabad
Experience: 4 to 10 Years
Domain: Medical Devices

Role Overview

We are looking for a System Engineer with 46 years of experience in System Engineering R&D;, preferably in the medical device domain. The candidate will work on system design, requirements management, risk analysis, system integration, verification, and compliance.

Mandatory Requirements

- 4 to10 years of experience in System Engineering R&D;
- Biomedical Engineering / Systems Engineering degree from a recognized university
- Strong experience in System Design and Systems Engineering
- Hands-on experience in Requirements Management
- Experience with risk analysis and DFMEA
- Experience in System Integration and Architecture
- Experience with requirements management tools such as DOORS / Jama
- Knowledge of medical device development and product lifecycle




- Experience with FDA Design Controls and regulatory standards
- Knowledge of standards such as 21 CFR, ISO 14971, IEC 60601
- Experience with verification and validation
- Knowledge of MBSE tools and methodologies
- Understanding of software lifecycle management / IEC 62304
- Experience working in Agile/Scrum and stage-gate environments
- Robust documentation and communication skills
- Ability to collaborate with PMO and global cross-functional teams

Preferred

- Master's degree in Biomedical / Systems Engineering
- Prior experience in medical device development
- Experience in circuit board development
- Experience with GMP and quality/regulatory compliance
- Experience in sustaining engineering / R&D; product development

📌 System Engineer (Hyderabad)
🏢 Teambees
📍 Hyderabad