17 Sep
|
Softive Technologies
|
Bengaluru
17 Sep
Softive Technologies
Bengaluru
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 setting. Dialysis Testing > Candidates with direct dialysis-machine testing experience should be given preference.
📌 Medical Device Test Engineer (Bengaluru)
🏢 Softive Technologies
📍 Bengaluru