System Engineer

Teambees Corp; Hyderabad; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Teambees Corp is seeking a System Engineer in Hyderabad with 4–10 years of System Engineering R&D experience, preferably in the medical devices domain. You will contribute to system design, requirements management, risk analysis, system integration, verification, and regulatory compliance.

The role requires familiarity with DOORS/Jama, MBSE approaches, and adherence to 21 CFR, ISO 14971, and IEC 60601 standards, along with Agile/Scrum and stage-gate processes.

Qualifications

• Must have 4–10 years in System Engineering R&D.
• Biomedical/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 DOORS/Jama.
• Knowledge of medical device development and product lifecycle.
• Experience with FDA Design Controls and regulatory standards.
• Knowledge of 21 CFR, ISO 14971, IEC 60601.
• Experience with verification and validation.
• Knowledge of MBSE tools/methodologies.
• Understanding of software lifecycle management / IEC 62304.
• Experience in Agile/Scrum and stage-gate environments.
• Strong documentation and communication skills.
• Collaboration with PMO and global cross-functional teams.

Skills

System Engineering R&D

System Design

Requirements Management

Risk analysis / DFMEA

System Integration and Architecture

FDA Design Controls

21 CFR, ISO 14971, IEC 60601 knowledge

Verification & Validation

MBSE tools & methodologies

Agile/Scrum & stage-gate

Documentation & communication

Cross-functional collaboration with PM

Education

Biomedical Engineering / Systems Engineering degree

Master's in Biomedical / Systems Engineering

Tools

DOORS

Jama

Job description

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
• Strong 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