Senior Cybersecurity Quality Systems Engineer

Senior Cybersecurity Quality Systems Engineer

About the role

The Senior Cybersecurity Quality Systems Engineer is a member of the Global Software Quality organization and serves as the Quality Systems subject matter expert for medical device cybersecurity. This role provides operational support to product development teams by independently reviewing cybersecurity documentation and objective evidence to ensure alignment with the Boston Scientific Quality System Global Software Quality procedures and applicable regulatory requirements.

The Senior Cybersecurity Quality Systems Engineer evaluates the completeness consistency and technical sufficiency of cybersecurity design outputs and supporting documentation to verify that cybersecurity activities have been performed in accordance with established Quality System processes and industry expectations. The role provides objective feedback identifies opportunities for improvement and partners with cross-functional teams to strengthen cybersecurity quality compliance and continuous improvement throughout the product lifecycle.

In addition this role serves as a key resource within Global Software Quality by monitoring evolving cybersecurity regulations standards and guidance and translating those expectations into Quality System procedures review methodologies and organizational best practices.

Your responsibilities will include

• Serve as the Global Software Quality subject matter expert for cybersecurity Quality System processes supporting medical devices software and connected systems.

• Perform independent reviews of cybersecurity documentation and product development deliverables to ensure alignment with the Boston Scientific Quality System Global Software Quality procedures and applicable regulatory requirements.

• Review cybersecurity objective evidence including threat models cybersecurity risk assessments security requirements software architecture documentation verification and validation evidence vulnerability assessments Software Bill of Materials (SBOM) and residual cybersecurity risk documentation.

• Assess the completeness traceability consistency and technical sufficiency of cybersecurity documentation to determine whether cybersecurity activities have been appropriately planned executed documented reviewed and approved.

• Provide objective feedback and practical recommendations to product teams regarding cybersecurity documentation Quality System compliance and process improvements.

• Partner with Research & Development Product Security Systems Engineering Software Engineering Regulatory Affairs and Quality organizations to resolve documentation and process gaps while maintaining an independent Quality Systems perspective.

• Support cybersecurity design reviews and development milestone reviews by evaluating cybersecurity deliverables against internal procedures and external regulatory expectations.

• Develop maintain and continuously improve Global Software Quality procedures work instructions review checklists templates and guidance related to medical device cybersecurity.

• Monitor changes to global cybersecurity regulations standards and industry guidance and assess their impact on the Boston Scientific Quality System.

• Lead implementation of Quality System updates resulting from new cybersecurity regulations standards and guidance.

• Identify systemic trends and recommend continuous improvements to cybersecurity Quality System processes across the organization.

• Support internal quality activities regulatory inspections CAPA investigations and quality improvement initiatives involving cybersecurity processes and documentation.

• Mentor and educate cross-functional teams on cybersecurity Quality System expectations and documentation best practices.

What were looking for in you:

Minimal qualifications:

• Bachelors degree in Computer Science Cybersecurity Software Engineering Computer Engineering Biomedical Engineering Electrical Engineering Quality Engineering or a related technical discipline.

• Minimum of5 years of experience in medical device software or cybersecurity and/or software quality within med device.

• Experience working within a regulated medical device Quality Management System.

• Demonstrated knowledge of secure software development lifecycle principles and cybersecurity risk management.

• Working knowledge of FDA medical device cybersecurity guidance IEC 62304 ISO 14971 medical device design controls and software development processes.

• Experience reviewing technical documentation and providing objective assessments of engineering deliverables.

• Strong analytical organizational written and verbal communication skills with the ability to collaborate across global cross-functional teams.

Preferred Qualifications

• Demonstrated knowledge of:

• FDA Quality Management System Regulation (QMSR)

• FDA Premarket and Postmarket Cybersecurity Guidance

• IEC

• ISO 13485

• AAMI TIR57

• AAMI TIR97

• NIST Cybersecurity Framework (CSF)

• NIST Secure Software Development Framework (SSDF)

• Secure software supply chain and Software Bill of Materials (SBOM) concepts

• Experience supporting connected medical devices Software as a Medical Device (SaMD) cloud-connected healthcare solutions or digital health technologies.

• Knowledge of cybersecurity considerations for Artificial Intelligence (AI) and Machine Learning (ML) enabled medical devices and healthcare software.

• Experience supporting regulatory inspections internal quality reviews CAPAs and continuous improvement initiatives.

• Professional certification such as CISSP CSSLP CQE CQA CISA or equivalent.