About This Role

Position Summary: As a Staff Product Security Analyst, you will play a critical role in safeguarding our medical devices by identifying, assessing, and mitigating security risks specific to the healthcare industry and medical devices. You will work closely with cyber security, development teams, product managers, and regulatory affairs to ensure that security is integrated into the product development lifecycle from the earliest stages, in compliance with Regulatory Agencies’ Cybersecurity requirements (e.g., FDA, BSI and PMDA).

Responsibilities:

Lead and own the end-to-end device product security management process with the following responsibilities:

· FDA Cybersecurity Compliance: Ensure compliance with FDA Cybersecurity guidance and regulations through collaboration with the Cyber Security, Regulatory and Quality, and Systems Development teams.

· Risk Assessments: Conduct comprehensive risk assessments of medical devices, identifying potential vulnerabilities and threats specific to the device hardware, firmware, and associated software.

· Threat Modeling: Develop and maintain cyber threat models for medical devices, considering factors such as patient safety, cyber security data privacy, and operational continuity.

· Software Bill of Materials (SBOM): Familiarity with SBOMs and the ability to communicate technical details effectively

· Product Security Policy documentation: Develop and maintain required medical device cyber security documentation as part of the device DHF including pre and post market cyber security activities and filings.

· Data Flow Diagrams: Ability to detail data flow diagrams at sufficient detail that can be leveraged throughout the threat modeling process.

· Security Design Reviews: Participate in security design reviews of medical device architectures and implementations, cybersecurity impact assessment from device design changes and providing recommendations for system security requirements that meet Regulatory and QMS requirements.

· Secure Coding Practices: Promote and guide secure coding practices within development teams, providing guidance and training specific to medical devices.

· Incident Response: Assist in the investigation and resolution of security incidents related to medical devices, coordinating with relevant teams to minimize impact and prevent future occurrences.

· Vulnerability Management: Assist the Cybersecurity team in execution and maintenance of the vulnerability identification program for medical devices, including vulnerability scanning, patching, and remediation.

· Data Privacy: Collaborate with the Privacy Team to ensure compliance with data privacy regulations, such as HIPAA, GDPR, and other applicable laws.

Qualifications:

· Bachelor's degree in computer science, information security, or a related field.

· 12+ years of experience in information security, with a focus on product security for medical devices.

· Strong understanding of security principles, methodologies, and tools specific to medical devices.

· Exceptional writing, editing, and proofreading abilities.

· Familiarity with content management systems (CMS) and/or document repository systems.

· Experience with vulnerability scanning, penetration testing, and threat modeling in the healthcare context.

· Expertise with FDA Cybersecurity guidance, regulations, and industry best practices.

· Familiarity with other Cybersecurity frameworks such as the NIST Cyber Security Framework and NIST SP 800-171.

· Knowledge of secure coding practices and development methodologies (e.g., Agile, DevOps) for medical devices.

· Experience with medical device design control requirements for software development and regulatory processes.

· Excellent problem-solving, analytical, and communication skills.

· Demonstrated ability to work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results. As well as creates formal networks involving coordination among groups within and outside of their assigned function.

Preferred Qualifications:

· Certifications such as CISSP, CISM, CISA, or specialized medical device security certifications.

· Experience with international medical device cybersecurity frameworks and standards (EU MDR, Japan JIS T 2304 (IEC 62304)).

· Knowledge of specific programming languages and technologies used in medical device development.

FLSA Status: Exempt

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