Senior Principal Engineer, Product Quality Cybersecurity Expert
3 days ago
Baxter International is seeking a highly skilled Sr. Principal Engineer, Product Quality Cybersecurity to join our team. As a key member of our Quality organization, you will play a critical role in ensuring the development and maintenance of our products meet regulatory standards, particularly in the realm of cybersecurity.
Key Responsibilities- Ensure all product development processes adhere to regulations (FDA and others as developed) and guidelines, with a focus on cybersecurity standards and requirements.
- Conduct risk assessments and manage risk throughout the product lifecycle, with a specific emphasis on cybersecurity risks and vulnerabilities.
- Collaborate with cross-functional teams to establish and maintain quality assurance processes, including the development of testing protocols and procedures for cybersecurity features.
- Provide guidance and training to team members on FDA design control requirements and cybersecurity principles, fostering a culture of compliance and quality throughout the organization.
- Serve as the product security technical expert within the Quality organization with responsibility for results in terms of product quality, performance, and safety.
- Bachelor's degree in engineering, computer science, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in FDA design control within the medical device or cybersecurity industry.
- Strong knowledge of cybersecurity principles, standards, and best practices, including Product Security (NIST Framework, FDA Cybersecurity guidance, MDCG), SOUP / OTS implementation, and vulnerability monitoring.
- Experience with risk management methodologies, such as cFMEA, Threat modeling (STRIDE, etc.).
- Ability to mentor employees within quality and across functions.
- Good communication and leadership skills.
- Estimated base salary range: $120,000 to $180,000 annually.
- Discretionary bonuses.
- Flexible workplace policy, including a minimum of 3 days a week onsite.
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