Software Quality Assurance Engineer (Systems & Design Controls)
Your tasks
About the Role We are seeking a Software Quality Assurance Engineer to take direct ownership of software quality, systems engineering discipline, and verification & validation (V&V) planning within our Singapore Software team.
In this role, you will act as the dedicated software-quality and systems counterpart to our Engineering Lead to assemble requirements, traceability, and routine regulatory submission evidence. You will own the requirements lifecycle—maintaining clean Software Requirements Specifications(SRS), building bidirectional requirement-to-test matrices, and partnering with product and clinical leads to ensure system specifications faithfully reflect clinical intent.
Rather than running daily manual test execution yourself, you will define the verification strategy, test coverage, and evidence completeness while partnering closely with our dedicated remote Software Test Engineer who executes test suites, regressions, and formal test reports. Over your first six months, you will be systematically mentored and developed to be come fully competent in regulatory software documentation, design controls, FDA premarket expectations, and cybersecurity standards for connected medical systems.
- Requirements Engineering & Systems Traceability
- Own, structure, and maintain Software Requirements Specifications (SRS) and end-to-end traceability matrices.
- Collaborate directly with Engineering Lead to extract and document interface contracts, and architectural constraints.
- Partner with Product and Clinical leads to guarantee user needs and clinical intent map seamlessly into downstream engineering specifications without ambiguity.
- Verification & Validation (V&V) Strategy &Coverage
- Define the software verification strategy, test plans, and requirement-to-test coverage criteria across mobile, web, backend, and cloud components.
- Partner closely with the Remote Software TestEngineer, who serves as the dedicated execution resource for executing test protocols, regression sweeps, retests, and initial test reports.
- Audit and sign off on test evidence completeness, ensuring test results satisfy verification acceptance criteria and pass regulatory scrutiny.
- In-Process Design Controls & Regulatory Submissions
- Build and maintain software quality and design-control documentation alongside the active sprint lifecycle rather than retrofitting or reconstructing records right before a release or submission.
- 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 (IEC 62304, ISO 13485, ISO 14971).
- Release Governance and Baseline Configuration
- 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 (e.g., Software Bill of Materials [SBOM], vulnerability assessments, threat modelling documentation, and patch management processes).
Requirements
Must-Haves
- Education: Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or a related discipline (or equivalent practical experience).
- Experience:
o 3+ to 5+ years of experience in software quality assurance, systems engineering, or software engineering with a primary focus on requirements management and V&V.
o Demonstrated track record managing structured Software Requirements Specifications (SRS) and end-to-end requirement traceability.
· Core Systems & Quality Acumen o Solid understanding of the complete Software Development Life Cycle (SDLC) across multi-tier environments (mobile, cloud, web, and APIs).
o Hands-on ability to read and critique technical design artifacts, API interfaces, and user stories to extract detailed verification criteria.
o Experience structuring test plans, acceptance criteria, and verification matrices mapped to system requirements.
- Delivery Discipline & Collaboration:
o Strong technical writing and communication skills; able to bridge clinical/product expectations, software architecture, and regulatory compliance.
o Proven capability to coordinate test execution with dedicated testers/engineers and hold the line on quality gates and release standards.
o Experience with modern issue tracking and requirements tooling (e.g., Jira, Confluence).
Good-to-Haves
- Familiarity or working exposure to medical device standards: IEC 62304 (Software Life Cycle), ISO 13485 (QMS), and ISO14971 (Risk Management).
- Familiarity with FDA premarket guidance for software, Digital Health/SaMD (Software as a Medical Device), or EU MDR software requirements.
- Understanding of basic medical device cybersecurity principles (e.g., FDA cybersecurity guidance, SBOMs, vulnerability reporting).
- Experience with automated testing tools, CI/CD pipelines, or connected IoT/BLE device ecosystems.