Sr. Manager / Sr. Staff, Software Quality (Cybersecurity)

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Position Summary:

As a Software Quality Engineer specializing in cybersecurity, you will be instrumental in ensuring the security, integrity, and compliance of software and products throughout the development lifecycle and post-market phases. The role involves implementing and maintaining cybersecurity best practices, overseeing post-market cybersecurity activities, conducting risk assessments, collaborating with cross-functional teams to enhance the overall security posture of products, and improving the cybersecurity aspects of software to meet regulatory requirements and industry standards.

Responsibilities:

• Develop and implement a comprehensive cybersecurity strategy within the software product domain.
• Provide leadership and guidance in aligning post-market cybersecurity initiatives with business objectives.
• Lead and/or mentor a team of experienced quality assurance professionals, offering expertise and support in the implementation of cybersecurity best practices.
• Foster a culture of compliance, quality, continuous learning, and innovation within the team.
• Collaborate closely with development and security team leaders to define and maintain medical device pre- and post-market security program activities. This includes, but is not limited to, security risk planning, security architecture, threat modeling, security risk assessment, scanning, penetration testing, and vulnerability management.
• Ensure process compliance with relevant regulatory requirements, including, but not limited to, FDA cybersecurity guidelines, ISO 13485, IEC 62304, ISO 14971, and other applicable regulations and standards.
• Collaborate with Product Security, Regulatory Affairs, and Product Development to interpret and implement pre- and post-market cybersecurity-related changes in regulations.
• Drive continuous improvement projects to advance processes and capabilities, especially in cybersecurity and software lifecycle.
• Establish and maintain best practices in the context of post-market medical device software cybersecurity.
• Oversee the development and execution of comprehensive test plans, with a specific focus on post-market cybersecurity testing.
• Collaborate with software development teams to ensure continuous monitoring and improvement of post-market cybersecurity measures.
• Develop and oversee incident response plans for post-market cybersecurity events related to software products.
• Develop and communicate expectations for continuous vulnerability management, covering identification, triage, analysis, and remediation recommendations.
• Conduct regular risk assessments and collaborate with cross-functional teams to implement effective risk mitigation strategies in post-market phases.
• Work closely with cross-functional teams, including development, security, operations, quality, and regulatory, to integrate cybersecurity measures seamlessly into the development lifecycle and post-market process.
• Actively participate in cross-functional meetings to address post-market cybersecurity concerns and requirements.
• Prepare and present regular reports on the status of post-market cybersecurity measures to senior leadership.
• Maintain thorough documentation of post-market cybersecurity processes and procedures.
• Coordinate the corporate corrective and preventive action program (customer complaints, audits, recalls, field corrections, and process changes) to ensure timely follow-up, completion, and documentation of corrective actions.
• Establish procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third-party audits.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• In-depth understanding of medical device regulations, FDA guidelines, and international standards related to post-market cybersecurity.
• Expert knowledge of product development, and specifical