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[Remote] Product Security Engineer - Medical Device/ FDA

Remote · Chile Full-time

Note: The job is a remote job and is open to candidates in USA. Avenue 45 is seeking a Product Security Engineer specializing in Medical Devices and FDA regulations. The role involves providing technical security expertise and supporting cybersecurity activities across product development and product-supporting systems, ensuring alignment with security policies and regulatory expectations.

Responsibilities

  • Work closely with the Cybersecurity Product Security team to support enterprise product security initiatives and cybersecurity programs
  • Provide technical product security leadership across product and R&D application development teams
  • Translate security requirements, architecture, and risk assessments into actionable design and implementation guidance
  • Review product and platform architectures, designs, and prototypes to ensure alignment with information security policies, standards, and guidelines
  • Support secure-by-design principles throughout the product development lifecycle (SDLC)
  • Participate as a product security subject matter expert in product development team meetings and design reviews
  • Assist with and perform vulnerability assessments of products and product-supporting systems
  • Support vulnerability scanning, reassessment, remediation validation, and patch/update tracking
  • Collaborate with development teams and the Cybersecurity Product Security team to address identified security risks and vulnerabilities
  • Serve as a security advisor to product, R&D, regulatory, quality, and commercial teams
  • Support customer- and partner-facing product cybersecurity discussions
  • Collaborate closely with the Cybersecurity Product Security team, GRC, and broader information security teams to ensure consistent application of cybersecurity standards and practices
  • Participate in security reviews, risk assessments, and cybersecurity governance activities related to product development and product-supporting environments
  • Stay current on product cybersecurity threats, trends, emerging attack techniques, and regulatory expectations
  • Share security best practices, lessons learned, and secure development guidance with engineering teams
  • Contribute to the continuous improvement of product security processes, standards, and tools

Skills

  • Bachelor's degree in Cybersecurity, Computer Science, Engineering, or related field, or equivalent experience
  • Min 6 – 8 years of experience with IT Security or Cybersecurity or related area
  • Min 2 years of experience in product security, application security, or cybersecurity supporting software-based products in medical devices area
  • Experience working in regulated environments. (FDA)
  • Experience collaborating with cybersecurity, product security, engineering, and cross-functional business teams
  • Strong understanding of secure architecture, application security, secure software development, and vulnerability management
  • Familiarity with web applications, cloud platforms (AWS/Azure), Windows, and Linux
  • Excellent communication skills and ability to work effectively across technical and business functions
  • Self-motivated and able to operate with minimal supervision
  • Ability to quickly understand complex product architectures and security requirements
  • Familiarity with FDA medical device cybersecurity guidance and industry standards such as IEC 81001-5-1, AAMI TIR57/TIR97, or NIST SSDF

Benefits

  • Remote contractor position
  • 1099 or Corp-to-Corp base contract
  • No w-2 contracts
  • Must be able to pass and clear background check and Drug Test prior to starting

Company Overview

  • Avenue 45 | Rachel Steffens, President – S-Corp | Senior Technical Recruiter | Freelance & Contract I am an experienced Senior Technical Recruiter specializing in freelance and contract recruitment, partnering with multiple clients and consulting firms to deliver top talent solutions. It was founded in 2023, and is headquartered in , with a workforce of 0-1 employees. Its website is https://www.avenue45info.com/.
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