Senior Principal Engineer, Product Quality Cybersecurity

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, it will 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 the mediocre. 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 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.

Vantive 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 Vantive 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 $150,000 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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US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our