Product Security Engineer (Medical Device/ FDA)

Hi, 

Hope you’re doing well!! 

Please find the requirement below. If you find yourself comfortable with the requirement please reply back with your updated resume or call me back at   

Position: Product Security Engineer - Medical Device/ FDA
Location: Remote
Duration: 6+ Months
Visa: Client won't be able to sponsor any visa
LinkedIN ID

The Product Security Engineer is a hands-on, individual contributor role responsible for supporting cybersecurity activities across product development and product-supporting systems. This role provides technical security expertise to ensure products are designed, developed, and maintained in alignment with organizational security policies, secure development best practices, and applicable regulatory expectations. 

The role works closely with the Cybersecurity Product Security team and partners with product development, R&D, quality, regulatory, commercial, and information security stakeholders to embed security into product architecture, design, implementation, and lifecycle activities. The ideal candidate is self-directed, adaptable, and capable of contributing immediately in a fast-paced product development environment. 

Background experience for Product Security Engineer 

Product Security supporting FDA-regulated medical devices or medical technology products. 

Hands-on cybersecurity / security experience with one or more of the following: 

• Software-based medical devices (SaMD)
• Diagnostic instruments (IVD)
• Connected medical devices
• Medical device software platforms
• Embedded medical device software
• Digital health products

Experience working within an FDA-regulated product development environment, partnering with R&D, Quality, and Regulatory teams. 

Knowledge of Secure Software Development Lifecycle (Secure SDLC) for medical devices. 

Experience conducting threat modeling, security risk assessments, vulnerability management, and security architecture reviews for regulated products. 

Familiarity with FDA medical device cybersecurity guidance and industry standards such as IEC 81001-5-1, AAMI TIR57/TIR97, or NIST SSDF is highly preferred. 

Required Qualifications 

Education & Experience

• Bachelor’s degree in Cybersecurity, Computer Science, Engineering, or related field, or equivalent experience.
• Min 7 - 10 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. 

Technical & Professional Skills

• 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. 

Key Responsibilities 

Product Security Engineering & Architecture

• 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). 

Secure Development & Lifecycle Support

• 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. 

Cross-Functional Collaboration & Advisory

• 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. 

Continuous Improvement & Knowledge Sharing

• 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.

Thanks & Regards:

Amar Pratap

Senior Technical Recruiter
VISION INFOTECH INC
Phone: ext 531
Direct:  
Email:  
368 Main Street, st #3, Melrose MA 02176

E-Verified Company