Principal Software Quality Engineer — Medical Devices (Hybrid)

Boston Scientific Corporation; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

The Principal Software Design Quality Engineer at Boston Scientific will lead software quality for complex cardiac devices, guiding risk management, design controls and regulatory compliance across the development lifecycle.

You will collaborate with cross-functional teams, mentor engineers, and ensure robust software verification and validation, cybersecurity alignment, and post-market support in a hybrid Arden Hills office environment.

Qualifications

• Bachelor’s degree in engineering, computer science, or related technical discipline with 9+ years in design quality or regulated software roles.
• Proven SDLC expertise and strong risk management experience.
• Extensive experience with software quality tools, JIRA, and requirements/test management platforms.
• Strong understanding of software configuration management and version control.
• Ability to lead cross-functional initiatives and communicate with leadership and regulators.

Responsibilities

• Serve as the primary software design quality lead for complex product development initiatives, from concept through commercialization.
• Drive risk management processes (ISO 14971) and integrate into the development process.
• Develop and maintain software risk management artifacts with traceability to requirements, design, and test artifacts.
• Collaborate with cybersecurity teams to ensure regulatory compliance and secure lifecycle.
• Apply sound, systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Work within a cross-functional team to implement effective controls for new technology in complex medical devices.
• Write technical documentation for procedure execution, rationale, and evidence of the development process.
• Support post-market activities of risk based on post-market signals.
• Participate in Design Change processes to ensure changes are thoroughly analyzed and assessed.
• Demonstrate knowledge of validation and statistical techniques in compliance with regulatory requirements and internal standards.
• Support verification, validation, and usability testing to meet internal and external requirements.
• Develop and maintain Design History File and Design Input/Output documentation.
• Demonstrate commitment to patient safety and product quality by adhering to Quality Policy.

Skills

SDLC

Risk management

Software verification & validation

JIRA experience

Version control systems

Cross-functional leadership

Technical communication

Problem solving

Education

Bachelor's degree in engineering, computer science, or related technical discipline

Tools

JIRA

Version control systems

Job description

The Principal Software Design Quality Engineer at Boston Scientific will lead software quality for complex cardiac devices, guiding risk management, design controls and regulatory compliance across the development lifecycle.

You will collaborate with cross-functional teams, mentor engineers, and ensure robust software verification and validation, cybersecurity alignment, and post-market support in a hybrid Arden Hills office environment.