3 дня назад
Sr. Manager, Medical Device Cyber Security
150 000 - 210 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Manager, Medical Device Cyber Security (Medical Device Cybersecurity): Owning and maturing the medical device cybersecurity program for Tempus AI's healthcare products with an accent on secure-by-design development, FDA compliance, and device lifecycle security. Focus on building cybersecurity roadmaps, managing SBOMs and vulnerabilities, supporting regulatory submissions, and coordinating penetration testing for hardware and embedded systems.
Location: Chicago, Illinois; hybrid
Salary: $150,000–$210,000 annually for roles performed from Illinois; ranges may vary for California, Colorado, and New York.
Company
develops a precision medicine platform that connects real-world evidence with clinical insights to support healthcare decision-making.
What you will do
- Own and continuously mature the medical device cybersecurity roadmap, policies, and standard operating procedures.
- Partner with R&D and engineering teams to integrate secure-by-design principles and SSDLC practices into medical device development.
- Define and manage Software Bill of Materials generation and maintenance across device product lines.
- Ensure medical device design and lifecycle management align with FDA pre-market and post-market cybersecurity guidance.
- Prepare and maintain cybersecurity documentation for 510(k), De Novo, and PMA submissions, and integrate cybersecurity into the Quality Management System.
- Oversee monitoring, vulnerability scanning, patching, penetration testing, and analyst mentorship.
Requirements
- 7+ years of technical information security experience in the technology or healthcare industry.
- Deep understanding of FDA cybersecurity guidance, ISO 14971, and ISO 13485.
- Proficiency in STRIDE or PASTA threat modeling and secure architecture design.
- Ability to manage multiple programs and align multidisciplinary stakeholders.
- Excellent written and verbal communication skills across biology, medicine, engineering, operations, and data science teams.
Nice to have
- CISSP, HCISPP, CISM, or relevant SANS certification.
Culture & Benefits
- Full-time employment with benefits that may include incentive compensation, restricted stock units, medical benefits, and other benefits depending on the position.
- Cross-functional collaboration across R&D, Product Management, Regulatory Affairs, Quality, and Information Security.
- Equal opportunity employment without discrimination based on protected characteristics.
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