Baxter
Senior Principal Engineer, Product Quality Cybersecurity
Baxter, Deerfield, Illinois, United States, 60063
Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.Your Role at Baxter: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 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.
Baxter 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 Baxter, 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 $180,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on 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.Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.
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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 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.
Baxter 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 Baxter, 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 $180,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on 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.Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.
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