Senior Principal Engineer, Product Quality Cybersecurity

Vantive: Una nueva empresa construída con base a nuestro legado

Desde el año pasado, Baxter ha emprendido un viaje para separar nuestro segmento de atención renal y convertirlo en una empresa independiente. Vantive* se basará en nuestro legado de casi 70 años en terapias agudas y diálisis domiciliaria y en los centros, para ofrecer la mejor atención a las personas a las que servimos. Creemos que Vantive no sólo construirá nuestro liderazgo en el ámbito de la atención renal, sino que además ofrecerá un trabajo significativo a quienes se unan a nosotros.

En Vantive, formarás parte de una comunidad de personas centradas, valientes y que no se conforman con lo mediocre. Cada uno de nosotros está motivado para ayudar a mejorar la vida de los pacientes en todo el mundo. Únete a nosotros para revolucionar el cuidado renal y de otros órganos vitales.

*La finalización de la propuesta de venta de Vantive a fondos gestionados por Carlyle Group, está sujeta a la recepción de las aprobaciones reglamentarias habituales y al cumplimiento de otras condiciones de cierre.

Your Role at Baxter:

As the Sr. Principal, Product Quality Cybersecurity, you will play a crucial role in guiding the development and maintenance of our products to meet regulatory standards, particularly in the realm of cybersecurity.

What you'll be doing:

• Ensure that 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 interacting frequently with leaders and functional peer group of technical experts.

• Interfaces with regulators or notified bodies during regulatory inspections.

• May participate in or manage quality security risk assessments of supplier’s products.

• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.

• Serves as a coach and trainer on product cybersecurity regulations and procedures

What you'll bring:

• 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, such 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.

• Good interpersonal/communication/influencing/negotiation skills.

Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $120,000 to $180,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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Equal Employment Opportunity

Baxter is an equal opportunity