Senior Systems Engineer

Teambees Corp

Hyderabad

Hybrid

INR 1,800,000 - 3,000,000

Full time

3 days ago
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Job summary

Teambees Corp in Hyderabad is seeking a Senior System Engineer with expertise in system engineering and medical device product development. You will design and integrate complex medical device systems, manage requirements, risk analyses, and ensure regulatory compliance.

Collaborate with cross-functional teams and global stakeholders, employing DOORS, JAMA, DFMEA, and MBSE tools to verify and validate designs in line with FDA Design Controls, ISO 14971, and IEC 60601.

Qualifications

  • Bachelor's degree in Biomedical Engineering or Systems Engineering.
  • Medical Devices or Healthcare or Medhealth Mandatory
  • 410 years of experience in System Engineering R&D, preferably in the medical devices domain.
  • Experience in system design, requirements management, and risk analysis.
  • Familiarity with DOORS, JAMA, DFMEA, and MBSE tools.
  • Knowledge of FDA Design Controls, ISO 14971, and IEC 60601.
  • Strong communication and stakeholder management skills.

Responsibilities

  • Design and integrate complex medical device systems.
  • Manage system requirements, architecture, verification, and validation.
  • Perform risk analysis, FMEA, and system integration activities.
  • Ensure compliance with medical device standards and regulatory requirements.
  • Collaborate with cross-functional teams and global stakeholders.

Skills

System engineering
Risk analysis
Requirements management
Regulatory compliance

Education

Biomedical Engineering
Systems Engineering

Tools

DOORS
JAMA
MBSE tools

Job description

Job Description:

We are looking for a Senior System Engineer with experience in system engineering and medical device product development.

Key Responsibilities:
  • Design and integrate complex medical device systems.
  • Manage system requirements, architecture, verification, and validation.
  • Perform risk analysis, FMEA, and system integration activities.
  • Ensure compliance with medical device standards and regulatory requirements.
  • Collaborate with cross-functional teams and global stakeholders.
Mandatory Requirements:
  • Degree in Biomedical Engineering or Systems Engineering.
  • Medical Devices or Healthcare or Medhealth Mandatory
  • 410 years of experience in System Engineering R&D, preferably in the medical devices domain.
  • Experience in system design, requirements management, and risk analysis.
  • Familiarity with DOORS, JAMA, DFMEA, and MBSE tools.
  • Knowledge of FDA Design Controls, ISO 14971, and IEC 60601.
  • Strong communication and stakeholder management skills.
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