Testing & Compliance Engineer – Electromedical Devices

Job Description – Testing Engineer (Electromedical Devices)

Position Title: Testing Engineer – Electromedical Devices

Department: Quality Assurance / Testing & Validation

Location: Mohali Sector 82

Role Overview:

The Testing Engineer will be responsible for conducting performance, safety, UPS backup, and compliance testing of electromedical devices in accordance with international standards (IEC 60601, ISO 13485, FDA, CE, etc.). The role involves developing and executing test plans, analyzing results, preparing reports, supporting product certification, and participating in regulatory and customer audits.

Key Responsibilities:

• Conduct testing of electromedical equipment to ensure compliance with safety, performance, UPS backup, and regulatory requirements.
• Carry out UPS and power supply testing for medical devices to validate backup performance, safety, and reliability.
• Develop, implement, and maintain test protocols, procedures, and validation plans.
• Perform electrical, mechanical, environmental, and functional testing on devices.
• Ensure compliance with standards such as IEC 60601 series, IEC 62304, ISO 14971, and relevant FDA/CE requirements.
• Prepare and maintain accurate test documentation, reports, and traceability records.
• Collaborate with R&D, Quality, and Regulatory teams during design verification and validation phases.
• Support certification processes with Notified Bodies, FDA, BIS, and other regulatory agencies.
• Participate in internal and external audits (ISO 13485, MDR, CE, FDA, BIS), ensuring testing-related processes meet compliance requirements.
• Assist in responding to audit findings and implementing corrective/preventive actions (CAPA).
• Troubleshoot failures and work with engineering/manufacturing teams to resolve design issues.
• Ensure calibration and maintenance of testing equipment and instruments.
• Continuously research and stay updated on evolving international standards for medical devices.

Qualifications & Skills:Education:

• Bachelor’s / Master’s degree in Biomedical Engineering, Electrical/Electronics Engineering, or a related discipline.

Experience:

• 2–5 years of experience in testing, validation, or quality assurance of electromedical/medical devices.
• Hands-on experience with compliance testing for IEC 60601 standards and UPS/power supply testing.
• Exposure to internal/external audits (ISO 13485, FDA, CE, MDR, BIS).
• Knowledge of ISO 13485, ISO 14971, IEC 62304, and regulatory guidelines.

Technical Skills:

• Proficiency in electrical/electronic testing instruments (oscilloscopes, multimeters, analyzers, simulators, UPS testers, etc.).
• Knowledge of medical device safety and risk management.
• Familiarity with software tools for test data acquisition and reporting.

Soft Skills:

• Strong analytical and problem-solving skills.
• Good communication and technical documentation skills.
• Ability to present during audits and interact with auditors/regulatory bodies.
• Attention to detail and adherence to compliance standards.

Key Performance Indicators (KPIs):

• On-time execution of test and validation activities.
• Accuracy and compliance of UPS and device test documentation.
• Positive outcomes in internal and external audits.
• Contribution to successful product certifications and approvals.

Job Types: Full-time, Permanent

Pay: From ₹20,000.00 per month

Work Location: In person

Speak with the employer
+91 7717302151