Principal Design Quality Cybersecurity Engineer

Boston Scientific is seeking an experienced Principal Design Quality Cybersecurity Engineer with a strong background in the design, development, and testing of cybersecurity features and controls within the Interventional Cardiology division. This individual will be responsible for overseeing and guiding the cybersecurity strategy throughout the product lifecycle, ensuring compliance with relevant standards and regulations.

The Interventional Cardiology team is one of Boston Scientific's most product-diverse divisions, supporting in the design of exciting new products and business development activities. These products adhere to industry standards and include computing devices, single-use devices, and support devices. Seeking an individual with a strong desire to analyze and drive solutions that are adaptable in communication to all levels within the organization.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week. Relocation assistance is available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance.
• Stay current with emerging regulations and standards related to medical device security (e.g., FDA Premarket Guidance, Post-market Cybersecurity Guidance).
• Collaborate with product development teams to embed security controls throughout the design, development, and maintenance phases.
• Ensure that medical device security engineering activities and deliverables (e.g., threat models, security risk assessments, security requirements, security test plans/protocols/reports, SBOM, post-market vulnerability management plans and reports, and cybersecurity labeling) comply with Boston Scientific's global quality system requirements and procedures.
• Collaborate with team on product security needs and requirements; review product security architectures and design specifications.
• Collaborate in planning of software verification and validation strategies.
• Review vulnerability assessments, fuzzing and penetration testing to identify and mitigate risks.
• Ensure continued consistent best practices and processes for secure coding, configuration management, and patching.
• Develop and implement risk mitigation strategies and maintain risk management documentation consistent across the ICTx portfolio.
• Oversee and enhance incident response plans and processes, ensuring rapid and effective resolution of security incidents.
• Drive continuous improvement of vulnerability management, including the evaluation and deployment of necessary patches or updates.
• Work closely with internal stakeholders (Software Development, R&D, Regulatory, IT, etc.) to align on security goals and requirements.
• Participate in internal and external audits, and address findings related to cybersecurity design and risk management processes.

What we're looking for in you:

Required qualifications:

• Bachelor's degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 9+ years of experience in cybersecurity engineering, with a focus on product development and risk management or
• Master's degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 7+ years of experience in cybersecurity engineering, with a focus on product development and risk management.
• Proven experience leading security design and architecture reviews for complex, embedded medical devices or similar technologies.
• Demonstrated track record of creating and executing security risk assessments and mitigation strategies.
• In-depth understanding of cybersecurity frameworks (e.g., NIST Cybersecurity Framework).
• Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity.
• Strong leadership, decision-making, and team-building capabilities.
• Excellent written and verbal communication skills for interfacing with technical teams, stakeholders, and executive leadership.
• Ability to work collaboratively across multidisciplinary teams, bridging gaps between technical, regulatory, and business functions.

Preferred qualifications:

• 5+ years of experience working in the medical device industry or a similarly regulated environment; security architecture or medical device administration experience in healthcare settings is also a plus.
• Hands-on experience with secure coding practices, vulnerability scanning tools, fuzzing, and penetration testing methodologies.
• Knowledge of embedded systems security, wireless communications, network protocols, and PKI.
• Familiarity with FDA regulations and guidance documents for medical devices (e.g., 21 CFR Part 820).
• Working knowledge of SW96/TIR57/TIR97, IEC 62304 (software lifecycle), IEC 60601 (electrical safety), and ISO 14971 (risk management).
• Experience supporting VA Handbook 6500 compliance and ISO/IEC 27001 certification.
• Relevant certifications (e.g., GIAC, OffSec, CISSP, CISM, CRISC) are a plus.