Exciting opportunity for a Software QA Engineer with at least 3 years’ experience to join a medical device company here in Singapore, to take direct ownership of software quality, systems engineering discipline, and V&V planning. Reporting into the Engineering Lead, you will define the verification strategy, test coverage, and evidence completeness while partnering closely with a dedicated remote Software Test Engineer who executes test suites, regressions, and formal test reports.

Role

• Own, structure, and maintain Software Requirements Specifications (SRS) and end-to-end traceability matrices.
• Extract and document interface contracts, and architectural constraints.
• Work with Product and Clinical leads to guarantee user needs and clinical intent map seamlessly into downstream engineering specifications without ambiguity.
• Audit and sign off on test evidence completeness, ensuring test results satisfy verification acceptance criteria and pass regulatory scrutiny.
• Own the software-quality documentation workstream, progressively taking on FDA premarket software documentation, design history files (DHF), verification summaries, and change-control records.
• Maintain a strong dotted-line working relationship with the Quality & Regulatory function to align software artifacts with international standards
• Support release-quality readiness reviews, defect triage meetings, configuration baselines, and release sign-offs.
• Evaluate and document controlled software change records, assessing regression impact before production deployment.
• Progressively take on cybersecurity documentation inputs, vulnerability assessments, threat modelling documentation, and patch management processes.

Requirements

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related discipline (or equivalent practical experience).
• More than 3 years of experience in software quality assurance, systems engineering, or software engineering with a primary focus on requirements management and V&V.
• Demonstrated track record managing structured Software Requirements Specifications (SRS) and end-to-end requirement traceability.
• Solid understanding of the complete Software Development Life Cycle (SDLC) across multi-tier environments (mobile, cloud, web, and APIs).
• Hands-on ability to read and critique technical design artifacts, API interfaces, and user stories to extract detailed verification criteria.
• Experience structuring test plans, acceptance criteria, and verification matrices mapped to system requirements.
• Strong technical writing and communication skills; able to bridge clinical/product expectations, software architecture, and regulatory compliance.
• Experience in Jira, Confluence or similar
• Experience with automated testing tools, CI/CD pipelines, or connected IoT/BLE device ecosystems advantageous

Interested candidates, please submit your profile to submitCV@talentreq.com for review. We will be in touch for initial discussion upon being shortlisted.

EA Licence: 17S8795 | EAP: R1108333