Senior Principal Engineer, Global Product Quality Cybersecurity - Remote

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, but also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous, and don’t settle for mediocrity. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role at Vantive:
As the Sr. Principal, Product Quality Cybersecurity, you will play a crucial role in guiding the development and maintenance of our products globally 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 a peer group of technical experts.

Interface with regulators or notified bodies during regulatory inspections.

Participate in or manage quality security risk assessments of supplier’s products.

Identify and lead continuous improvement projects aimed at achieving quality, reliability, and cost improvements.

Serve 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; an advanced degree is preferred.

Significant 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.

Strong interpersonal, influencing, and negotiation skills.

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