Staff Software Quality Engineer – Product Development
Core
Senior quality partner providing technical leadership and oversight to ensure software products comply with company requirements, regulations, and industry standards while driving risk-based decision making.
Role type
Staff Software Quality Engineer (Individual Contributor)
Builds
Regulated software products (SaMD, cloud-enabled, AI-enabled, data-driven) for health equity and disease detection/diagnosis
Domain
Life Sciences / Genomics / Medical Devices / Regulated Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
software quality engineering, software development, systems engineering, regulatory compliance (IEC 62304, ISO 13485, QMSR, FDA), software verification, validation, risk management, cybersecurity, cross-functional leadership, mentoring engineers, strategic initiative leadership, audit support, process improvement, emerging technology assessment
Preferred skills
experience with Software as a Medical Device (SaMD), regulatory inspections and audits, quality/regulatory certifications (ASQ, AAMI, RAPS)
Technologies
IEC 62304, ISO 13485, QMSR, FDA regulations, SaMD, cloud platforms, AI frameworks
Responsibilities
Provide software quality leadership across multiple product development programs throughout the SDLC and PDP; Review and approve software lifecycle deliverables including requirements, design documentation, traceability records, and cybersecurity documentation; Lead resolution of complex software quality, compliance, and risk management challenges using a risk-based approach; Mentor and coach Software Quality Engineers and cross-functional stakeholders on software quality processes and regulatory expectations; Facilitate quality alignment across Software Development, Product Security, Regulatory Affairs, Product Management, and Program Management functions; Support complaint investigations, CAPA activities, audit observations, and corrective action initiatives; Assess emerging technologies and development methodologies to identify quality and compliance improvement opportunities; Act as a trusted advisor within the Software Quality organization to shape future quality capabilities and operating practices.
Seniority
Staff, strategic leadership & mentorship