Senior Software Quality Engineer – Medical Devices

Nalu Medical, Inc.; Sacramento (CA); Hybrid; USD 102,000 - 194,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific seeks a Principal Software Design Quality Engineer to lead design quality for active implantable devices, driving risk management and software V&V within a hybrid work setting. You will mentor engineers, collaborate across functions, and ensure cyber and regulatory compliance throughout the product lifecycle.

Responsibilities include leading quality processes, maintaining DHF, and supporting post-market activities while influencing cross-functional decisions to elevate design

Qualifications

• Bachelor's degree in engineering, computer science, or related discipline with 9 years in design quality or regulated domains.
• Proven expertise in SDLC, risk management, and software verification and validation.
• Experience with software quality tools (JIRA) and requirements/test management platforms.
• Deep understanding of software configuration management and version control.
• Ability to lead cross-functional initiatives and influence without authority.
• Strong verbal and written communication with regulatory exposure.

Responsibilities

• Serve as the primary software design quality lead for complex product development from concept through commercialization.
• Drive risk management processes (ISO 14971), hazard analyses, software FMEAs, and security risk analyses.
• Develop and maintain software risk management tools with traceability to requirements, design, and tests.
• Collaborate with cybersecurity teams to ensure compliance with evolving security requirements.
• Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
• Work with cross-functional teams to implement controls for new technology in medical devices.
• Maintain Design History File and related product specifications and prints.
• Support post-market activities and evidence-based risk monitoring as needed.
• Contribute to Design Change processes with thorough analysis and assessment.

Skills

SDLC

Risk management

Software verification and validation

JIRA

Requirements management

Version control / CM

Cross-functional leadership

Regulatory knowledge

Communication

Problem solving

Education

Bachelor's degree in engineering or computer science

Tools

JIRA

Requirements/Test management tools

Software configuration management

Job description

Boston Scientific seeks a Principal Software Design Quality Engineer to lead design quality for active implantable devices, driving risk management and software V&V within a hybrid work setting. You will mentor engineers, collaborate across functions, and ensure cyber and regulatory compliance throughout the product lifecycle.

Responsibilities include leading quality processes, maintaining DHF, and supporting post-market activities while influencing cross-functional decisions to elevate design