仕事内容

Overview

We are looking for an experienced Software Test Engineer specializing in Verification and Validation (V&V) activities for medical device software. The role focuses on assuring software quality, safety, and adherence to regulatory standards through comprehensive testing, defect management, and detailed documentation suitable for audits.

Key Responsibilities

Create and implement test plans, cases, and validation protocols derived from system and software requirements.
Maintain full Requirement Traceability Matrix (RTM) linking requirements, test cases, and defects.
Design and carry out tests based on IEC 62304 and ISO 13485 medical software lifecycle and quality management standards.
Perform risk-based testing in line with ISO 14971, including failure mode effects analysis (FMEA) and hazard evaluation.
Log, track, and analyze defects using tools such as JIRA and ALM, conducting root cause analysis for issues.
Work collaboratively with hardware, firmware, QA, and regulatory teams during design reviews and problem-solving processes.
Test real-time software behavior to verify deterministic system response.
Compile verification and validation documentation prepared for regulatory audit readiness (FDA and CE compliance).

Required Qualifications and Experience

Bachelor's or Master’s degree in Biomedical, Electrical, Software, Electronics, or Systems Engineering (BE/BTech/MTech/ME).
A minimum of 3 years and up to 8 years of hands-on experience in software V&V specifically for medical device products.
Strong proficiency in design controls, risk management, and regulatory requirements for medical software development.
Experienced in test creation, execution, defect documentation, and maintaining compliance within regulated environments.
Excellent analytical capabilities along with solid communication and documentation skills.

Technical Skills and Tools

Expertise in test case design methods such as boundary value analysis, equivalence partitioning, and state-based testing.
Knowledge of automation scripting languages preferably Python.
Familiarity with test management and defect tracking tools including JIRA, ALM, Putty, and DOORS.
Experience using automation and scripting platforms like Python and MATLAB.
Skills in debugging and analysis tools including serial log analysis and logic analyzers.
Working knowledge of medical software standards: IEC 62304, ISO 13485, ISO 14971, and IEC 60601.

Deliverables

Validated and verified software releases ready for deployment.
Comprehensive test documentation demonstrating requirement traceability.
Defect reports and evidence of closure.
Complete audit-ready compliance documentation.

Software Verification and Validation Engineer - Medical Devices

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