Senior Principal Engineer, Global Product Quality Cybersecurity - Remote

Vantive Health LLC; Madrid; A distancia; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

A leading company in vital organ therapy is seeking a Sr. Principal, Product Quality Cybersecurity. This role involves ensuring compliance with cybersecurity regulations, conducting risk assessments, and collaborating with cross-functional teams to enhance product quality. The candidate should have significant experience in the medical device industry and strong knowledge of cybersecurity standards.

Formación

• 5+ years of experience in FDA design control in medical device or cybersecurity industry.
• Strong knowledge of cybersecurity standards (NIST, FDA guidance).
• Mentorship of employees across functions.

Responsabilidades

• Ensure product development processes meet FDA regulations with a focus on cybersecurity.
• Conduct risk assessments and manage cybersecurity vulnerabilities.
• Provide guidance on FDA design control and train team members on procedures.

Conocimientos

Cybersecurity principles

Risk management methodologies

Communication skills

Leadership skills

Negotiation skills

Educación

Bachelor's degree in engineering, computer science, or related field

Advanced degree (preferred)

Descripción del empleo

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.

Position : Sr. Principal, Product Quality Cybersecurity

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 all product development processes adhere to regulations (FDA and others) with a focus on cybersecurity standards.
• Conduct risk assessments and manage risks throughout the product lifecycle, emphasizing cybersecurity vulnerabilities.
• Collaborate with cross-functional teams to establish quality assurance processes, including testing protocols for cybersecurity features.
• Provide guidance and training on FDA design control requirements and cybersecurity principles, fostering a culture of compliance.
• Serve as the product security technical expert within the Quality organization, interacting with leaders and technical peers.
• Interface with regulators or notified bodies during inspections.
• Participate in or manage security risk assessments of suppliers’ products.
• Lead continuous improvement projects to enhance quality, reliability, and cost efficiency.
• Coach and train team members on product cybersecurity regulations and procedures.

What you'll bring :

• Bachelor's degree in engineering, computer science, or related field; advanced degree preferred.
• At least 5 years of experience in FDA design control within the medical device or cybersecurity industry.
• Strong knowledge of cybersecurity principles, standards (e.g., NIST Framework, FDA guidance), and vulnerability monitoring.
• Experience with risk management methodologies such as cFMEA and threat modeling (e.g., STRIDE).
• Ability to mentor employees across functions.
• Excellent communication and leadership skills.
• Strong interpersonal, influencing, and negotiation skills.

Vantive is committed to providing reasonable accommodations for individuals with disabilities. If you require accommodations during the application or interview process, please click here to request assistance.

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