Software Quality Engineer

Engineer, Software Quality

Location: Pleasanton, CA

Work Arrangement: 100% Onsite

Duration: Contract – 12 Months

Potential: Possibility of conversion to permanent

Business Unit: Heart Failure

Hours: Monday–Friday, 8:00 AM–5:00 PM

Position Overview

We are seeking an Engineer, Software Quality to support software quality, compliance, verification and validation, risk management, and continuous improvement activities within a regulated medical device environment. This role will work closely with Software Engineering, Systems Engineering, Quality, Regulatory, Cybersecurity, and other cross-functional teams to ensure software and system development activities meet applicable quality and regulatory requirements. The ideal candidate will have a strong quality and process-oriented background with an understanding of software development and validation, rather than a heavy software testing or test automation background.

Key Responsibilities

• Support software verification and validation (V&V) activities, including development and review of test protocols, plans, reports, and related quality documentation.
• Support assessments of non-product software and associated quality requirements.
• Support product cybersecurity assessments in collaboration with cross-functional teams.
• Review software and system documentation to ensure quality, consistency, and regulatory compliance.
• Maintain requirements traceability and support software development lifecycle (SDLC) processes.
• Perform and support risk assessments, including FMEA and hazard analysis.
• Identify quality issues, facilitate root-cause analysis, and support timely issue resolution.
• Participate in sustaining engineering activities, including post-release support and issue resolution.
• Participate in design reviews and represent Quality during applicable review and approval activities.
• Support post-release software changes and ensure appropriate quality and compliance processes are followed.
• Support internal and external audits, including audit readiness and response activities.
• Identify and support quality system and process improvements.
• Collaborate with cross-functional teams to ensure compliance with applicable FDA and industry requirements.
• Contribute to continuous improvement of software quality processes, documentation, and controls.

Required Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.
• Minimum 2 years of experience in software quality, software validation, systems engineering, quality engineering, or a related discipline.
• Experience working within a regulated industry, preferably medical devices, diagnostics, pharmaceutical, or another highly regulated environment.
• Understanding of software quality and software verification and validation processes.
• Experience with requirements traceability and software development lifecycle processes.
• Knowledge of risk management, including FMEA and/or hazard analysis.
• Strong understanding of quality and compliance principles.
• Strong analytical, problem-solving, written, and verbal communication skills.
• Ability to work independently with minimal supervision while collaborating effectively with cross-functional teams.

Preferred Qualifications

• Experience in a medical device environment.
• Knowledge of FDA regulations and quality requirements.
• Experience with ISO 13485.
• Experience with IEC 62304.
• Experience supporting quality or regulatory audits.
• Experience with CAPA, nonconformance, deviation, or issue-resolution processes.
• Experience with process improvement and quality system improvement initiatives.
• Familiarity with software cybersecurity quality requirements.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.