Lead Software Quality Engineer - Medical Devices

BD; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD, a global leader in medical technology, seeks a Principal Engineer in Software Quality to define and execute robust QA processes across the software lifecycle, ensuring safe and effective medical device software throughout development.

The role collaborates with software, regulatory affairs, and management to drive risk assessment, design and code reviews, test strategy, and continuous improvement in a regulated environment.

Qualifications

• Bachelor's or Master's degree in a technical field (CS, software eng, biomedical eng).
• 10+ years in software quality assurance or software engineering, with 5+ years in lead roles.
• Deep knowledge of SDLC methodologies in regulated contexts (Agile, Waterfall).
• Strong knowledge of medical device regulations (FDA QSR/21 CFR Part 820, ISO 13485, IEC 62304).
• Analytical, problem-solving, and communication skills with cross-functional collaboration.

Responsibilities

• Develop and maintain software quality assurance strategies and procedures per regulatory requirements (FDA, ISO 13485, IEC 62304).
• Lead review of design, development, and test plans for complex software systems including embedded, app, and cloud solutions.
• Perform risk analysis and mitigate software defects; lead root cause analyses and CAPA actions.
• Drive continuous improvement of QA processes, tools, and metrics in a regulated environment.
• Collaborate with software development, regulatory affairs, and management throughout the product lifecycle.

Skills

Quality assurance strategies

Test plans & automation

Risk management for software

Defect management leadership

Design & code reviews

Test levels (unit to regression)

Root cause analysis

Regulatory compliance (FDA ISO)

Cross-functional collaboration

Technical leadership

Education

Bachelor's or Master's in CS/Software Eng/Biomedical Eng

Tools

Polarion ALM

Job description

BD, a global leader in medical technology, seeks a Principal Engineer in Software Quality to define and execute robust QA processes across the software lifecycle, ensuring safe and effective medical device software throughout development.

The role collaborates with software, regulatory affairs, and management to drive risk assessment, design and code reviews, test strategy, and continuous improvement in a regulated environment.