MedTech Product Security Engineer — FDA‑Ready Cybersecurity

Cognito Therapeutics, Inc.; United States; Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Unlimited PTO

Wellness perks

Virtual medical support

Health insurance

Dental insurance

Vision insurance

Job summary

Cognito Therapeutics, Inc. is seeking a Product Security Engineer to join the Security, Privacy, and IT organization.

You will work with hardware, software, and systems engineers to build security into product design, own the cybersecurity portions of our FDA submission, and run security operations for the product in the field. Reporting to the Information Security Director, you will drive threat modeling, risk management, and post-market security activities, with a hybrid work arrangement in

Qualifications

• 8+ years of product/security experience in a medical device environment.
• Hands-on for FDA submission content: SBOM, risk assessments, security architecture views.
• Experience working within a Quality Management System (ISO 13485, 21 CFR 820).
• Experience integrating cybersecurity risk into medical device risk management (ISO 14971).
• Collaborative work with hardware, software, and systems engineers on secure design.

Responsibilities

• Partner with hardware, software, and systems engineers to build security into product design from the start.
• Own system-level threat modeling and feed security requirements into design reviews.
• Lead cybersecurity content for FDA submissions and respond to FDA questions.
• Manage security risk assessments and ensure QMS traceability and change control.
• Plan and execute (or coordinate) security testing, including post-market monitoring and SBOM tracking.
• Run vulnerability management for the fielded product and coordinate third-party testing.
• Serve as embedded security contact across engineering teams and develop reusable security documentation.

Skills

Product security

FDA submissions

Risk management

Cross-functional collaboration

Education

Bachelor's degree in CS/CE/EE

Tools

ISO 13485/21 CFR 820

Job description

Cognito Therapeutics, Inc. is seeking a Product Security Engineer to join the Security, Privacy, and IT organization.

You will work with hardware, software, and systems engineers to build security into product design, own the cybersecurity portions of our FDA submission, and run security operations for the product in the field. Reporting to the Information Security Director, you will drive threat modeling, risk management, and post-market security activities, with a hybrid work arrangement in