Product Security Engineer (Med Device)

Insight Global; Warsaw (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Insight Global is seeking a Product Security Engineer to own the cybersecurity governance process for SaMD products within a Design History File workspace. You will maintain and improve cybersecurity documentation, vulnerability management, risk management, and regulatory artifacts under evolving FDA regulations.

The role is strategic and embedded within one or two high-visibility SaMD teams, leading security requirements, threat analyses, and oversight of testing outputs while driving

Qualifications

• 5+ years of experience in Product Security, Application Security, Medical Device Security, or Cybersecurity Engineering.
• Experience with recognized security frameworks and secure development practices.
• Experience authoring and reviewing cybersecurity requirements.
• Strong understanding of secure coding principles and common software vulnerabilities.
• Experience conducting Threat Modeling using STRIDE methodology.
• Experience performing Secure Architecture Reviews.
• Software Vulnerability Management processes – 3rd party management.
• Experience conducting Threat Assessments and Vulnerability Assessments.
• Experience utilizing CVSS scoring methodologies.
• Experience reviewing SBOMs (Software Bill of Materials).
• Experience evaluating CVEs and CWEs.
• Understanding SDLC and software engineering practices.
• Cloud security and configuration experience.
• Familiarity with FDA Cybersecurity Guidance.
• Experience with IEC 62304 and ISO 14971.
• ISO 27001 experience.
• HIPAA experience.
• GDPR/privacy experience.
• SaMD experience.
• FDA submission support.
• Cybersecurity risk management files.
• Penetration testing knowledge.
• Connected device/IoT security.
• CISSP, CSSLP, Security+ or similar certifications.

Skills

Product Security

Application Security

Medical Device Security

Cybersecurity Engineering

Threat Modeling (STRIDE)

Secure Architecture Reviews

Vulnerability Management

SBOMs

CVE/CWE evaluation

SDLC

Cloud Security

FDA Cybersecurity Guidance

IEC 62304

ISO 14971

ISO 27001

HIPAA

GDPR

SaMD

FDA submission support

Cybersecurity risk management files

Penetration testing

IoT security

CISSP

CSSLP

Security+

Job description

Job Description

We are seeking a Product Security Engineer to own and lead the cybersecurity governance process for Software as a Medical Device (SaMD) products within a strategic Design History File (DHF) workspace. This individual will be responsible for maintaining and improving cybersecurity documentation, vulnerability management processes, risk management activities, and compliance artifacts required under evolving FDA cybersecurity regulations. The role is highly strategic and process-oriented, serving as the security lead embedded within one or two high-visibility SaMD teams. Responsibilities include defining security requirements, reviewing threat analyses, assessing the effectiveness of security controls, overseeing cybersecurity testing outputs, and ensuring documentation remains current as product designs evolve. The ideal candidate will drive continuous improvement of cybersecurity and risk management processes, maintain ownership of all required regulatory documentation, and partner closely with cross-functional engineering and quality teams to ensure ongoing compliance and product security. This is a leadership role without direct people management responsibilities and is focused on governance, oversight, and strategic decision-making rather than hands-on technical implementation.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

Skills and Requirements

• 5+ years of experience in Product Security, Application Security, Medical Device Security, or Cybersecurity Engineering


• Experience working within recognized security frameworks and secure development practices


• Experience authoring and reviewing cybersecurity requirements


• Strong understanding of secure coding principles and common software vulnerabilities


• Experience conducting Threat Modeling using STRIDE methodology


• Experience performing Secure Architecture Reviews


• Experience with Software Vulnerability Management processes – 3rd party management


• Experience conducting Threat Assessments and Vulnerability Assessments


• Experience utilizing CVSS scoring methodologies


• Experience reviewing SBOMs (Software Bill of Materials)


• Experience evaluating CVEs and CWEs


• Strong understanding of SDLC and software engineering practices


• Cloud security and configuration experience


• Familiarity with FDA Cybersecurity Guidance


• Experience with IEC 62304 and ISO 14971


• ISO 27001 experience


• HIPAA experience


• GDPR/privacy experience


• SaMD experience


• FDA submission support


• Cybersecurity risk management files


• Penetration testing knowledge


• Connected device/IoT security


• CISSP, CSSLP, Security+ or similar certifications