Medical Device Test Engineer

Softive Technologies Pvt. Ltd.; Bengaluru; Vor Ort; INR 450.000 - 600.000; Vollzeit

Zusammenfassung

Softive Technologies Pvt. Ltd. is seeking a Medical Device Test Engineer / V&V Engineer with 1–2 years of experience to perform comprehensive testing of dialysis equipment and related medical devices.

The role focuses on end-to-end system tests, performance, alarm and safety checks, and regulatory file readiness, with hands-on use of test instruments and meticulous documentation. Ideal candidates will have hands-on testing skills, knowledge of test methodologies, and the ability to maintain

Qualifikationen

• 1–2 years of relevant experience in medical device testing, V&V, system testing or functional testing.
• Hands-on experience with test instruments and documentation for regulatory viability.

Aufgaben

• End-to-End System Testing of dialysis equipment and related devices.
• Performance testing to verify key parameters under normal and boundary conditions.
• Alarm and safety testing of critical functions and alarms.
• Production-equivalent testing to simulate real-world usage.
• User-based/usability testing to ensure patient and operator friendliness.
• Maintain complete V&V test documentation and traceability for quality records.
• Use test instruments and calibration practices to ensure accurate measurements.

Kenntnisse

Medical device testing

V&V

System testing

Functional testing

Performance testing

Hardware testing

Embedded testing

Diagnostic equipment testing

Patient-monitoring testing

Critical-care testing

Ausbildung

B.Sc./M.Sc. in Physics, Medical Instrumentation, Life Sciences or related discipline

Jobbeschreibung

We are looking for a Medical Device Test Engineer / V&V Engineer with 1-2 years of experience in medical device testing, system testing, verification & validation, or regulated product testing.

The candidate will be responsible for executing functional, performance, alarm, safety, system and end-to-end testing of medical equipment. The role will primarily involve testing of dialysis equipment, and candidates with experience in other medical devices, diagnostic equipment, patient-monitoring systems or critical-care equipment may also be considered.

The ideal candidate should have strong hands-on testing skills, good understanding of test methodologies, experience with test instruments, and the ability to maintain accurate test records and V&V documentation.

Key Responsibilities

1. End-to-End System Testing

• Execute complete end-to-end testing of the dialysis machine covering:
• Execute approved test cases and test protocols.
• Verify system behavior under normal, abnormal and boundary conditions.
• Identify, document and track defects.
• Support regression testing following defect fixes or hardware/software changes.

2. Performance Testing -Verify critical performance parameters,

3. Alarm & Safety Testing -Execute testing of critical alarms and safety functions

4. Production-Equivalent Testing

5. User-Based / Usability Testing

6. Test Documentation & V&V

Ensure test documentation is complete, accurate, traceable and suitable for quality and regulatory documentation.

7. Test Instruments & Equipment

The candidate should have hands-on experience using relevant test and measurement equipment.

The candidate should understand basic calibration requirements and ensure appropriate test equipment is used during testing.

Required Qualifications

Educational Qualification

Candidates with a B.Sc./M.Sc. in Physics, Medical Instrumentation, Life Sciences or a related discipline may also be considered if they have relevant medical-device testing experience.

Experience

1–2 years of relevant experience in one or more of the following:

• Medical device testing
• Verification & Validation (V&V)
• System testing
• Functional testing
• Performance testing
• Hardware testing
• Embedded/medical equipment testing
• Diagnostic equipment testing
• Patient-monitoring equipment testing
• Critical-care equipment testing, etc;

Ideal Candidate Profile

A suitable candidate could come from any of the following backgrounds:

Biomedical / Medical Device Testing > 1-2 years of experience testing medical devices with hands-on exposure to system, functional and performance testing.

Electronics / Instrumentation Testing > 1-2 years of experience testing electronic/instrumentation-based products, with exposure to measurement instruments and hardware/system testing.

Diagnostic / Patient Monitoring Equipment > Experience testing analyzers, patient monitors, infusion systems or similar healthcare equipment.

Embedded Product Testing > Experience in system-level testing of embedded products, preferably in a regulated or safety-critical environment.

Dialysis Testing > Candidates with direct dialysis-machine testing experience should be given preference.