Leading design quality engineering activities across the software development lifecycle
from risk assessments and quality planning through design reviews, V&V, and post-market monitoring.
Reviewing and approving design input/output artifacts including requirements documents, design specifications, code reviews, and verification and validation test plans and reports.
Ensuring all software design controls are compliant with IEC 62304, ISO 13485, and other applicable regulatory guidance
and that compliance is demonstrated, not assumed.
Developing and maintaining risk analysis tools and risk management plans across Foresight’s suite of software systems.
Creating and revising SOPs to define software quality and release readiness requirements, shepherding documents through design and documentation control processes.
Supporting and leading cross-functional validation planning efforts for software systems, coordinating with teams on timely remediation of compliance gaps.
Managing NCR and CAPA processes
investigating and resolving end-user issues, tracking metrics and closing the loop.
Supporting cybersecurity process adherence across the product portfolio.
Participating in external audits with regulatory bodies including CAP, CLIA, and ISO certification bodies.
Monitoring process efficiency through internal audits and reporting that drives real improvement.

Minimum of 3-5 years of software quality engineering experience in a regulated environment (FDA, ISO, CAP/CLIA, or equivalent).
Hands-on experience executing IEC 62304 software development lifecycle requirements in conjunction with ISO 13485 design controls.
Demonstrated ability to define, implement, and maintain compliant software development, execution, and documentation.
Strong autonomy and project ownership: you can drive complex, cross-functional work without waiting to be told what to do next.
Bachelor’s degree in software engineering, computer science, information technology, or a closely related field.
Exceptional interpersonal and collaboration skills
you work as well with lab scientists as you do with software engineers.

Software Design Quality Engineer

Key skills