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Senior Principal Engineer, Global Product Quality Cybersecurity - Remote

Vantive

Madrid

A distancia

USD 100.000 - 150.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Vantive is seeking a Senior Principal Engineer focused on Global Product Quality Cybersecurity. In this remote role, you will ensure regulations and standards are met in product development. Ideal candidates will have a strong background in cybersecurity, FDA compliance, and experience in the medical device industry.

Formación

  • 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.
  • Ability to mentor employees within quality and across functions.

Responsabilidades

  • Ensure product development processes adhere to regulations, focusing on cybersecurity standards.
  • Conduct risk assessments and manage cybersecurity risks throughout the product lifecycle.
  • Provide guidance and training to team members on FDA design control and cybersecurity principles.

Conocimientos

Cybersecurity principles
Risk management methodologies
FDA design control
Product Security
Leadership skills

Educación

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

Descripción del empleo

Senior Principal Engineer, Global Product Quality Cybersecurity - Remote

Vantive Madrid, Community of Madrid, Spain

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Senior Principal Engineer, Global Product Quality Cybersecurity - Remote

Vantive Madrid, Community of Madrid, Spain

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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.
  • 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.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Digitalization & Systems Engineering (Applying / Overseeing (2)), Operational Quality Assurance (Applying / Overseeing (2))

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and / or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Seniority level

  • Seniority level Mid-Senior level

Employment type

  • Employment type Full-time

Job function

  • Job function Engineering and Information Technology
  • Industries Medical Equipment Manufacturing

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