Senior Principal Engineer, Global Product Quality Cybersecurity - Remote

Deerfield, Illinois; Marbella; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A healthcare technology company in Spain is looking for a Sr. Principal, Product Quality Cybersecurity. In this role, you will ensure product development meets regulatory standards, conduct risk assessments, and collaborate with teams on quality assurance processes. Candidates should have a Bachelor's degree and at least 5 years of experience in FDA design control. This is a unique opportunity to make a significant impact in the healthcare technology field.

Formación

• Minimum of 5 years of experience in FDA design control.
• Strong knowledge of NIST Framework and FDA Cybersecurity guidance.
• Experience with risk management methodologies like cFMEA.

Responsabilidades

• Ensure all product development meets regulatory standards.
• Conduct risk assessments with a focus on cybersecurity.
• Collaborate to maintain quality assurance processes.

Conocimientos

Cybersecurity principles

FDA design control

Risk management methodologies

Communication skills

Leadership skills

Educación

Bachelor's degree in engineering or computer science

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.

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.
• Interface with regulators or notified bodies during regulatory inspections.
• May participate in or manage quality security risk assessments of supplier’s products.
• Identify and lead continuous improvement projects with the objective of 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; 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 as 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.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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