Senior Cybersecurity Quality Systems Engineer (Med Devices)

Boston Scientific Gruppe; Marlborough (MA); On-site; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific Marlborough, MA is seeking a Senior Cybersecurity Quality Systems Engineer to join the Global Software Quality organization. You will serve as the Quality Systems SME for cybersecurity of medical devices, reviewing documentation to ensure alignment with Quality System and regulatory requirements.

You will monitor evolving regulations, develop procedures, and collaborate with R&D, Product Security, Regulatory Affairs and Quality to drive improvements across the product lifecycle.

Qualifications

• Bachelor's degree in a relevant technical discipline.
• Minimum of 5 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.

Responsibilities

• 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.

Skills

Cybersecurity

Quality Systems

Regulatory knowledge

Analytical skills

Communication skills

Education

Bachelor's degree in Computer Science, Cybersecurity, Software Engineering, Computer Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline

Job description

Boston Scientific Marlborough, MA is seeking a Senior Cybersecurity Quality Systems Engineer to join the Global Software Quality organization. You will serve as the Quality Systems SME for cybersecurity of medical devices, reviewing documentation to ensure alignment with Quality System and regulatory requirements.

You will monitor evolving regulations, develop procedures, and collaborate with R&D, Product Security, Regulatory Affairs and Quality to drive improvements across the product lifecycle.