Job Title: Senior Product Security Architect Medical Devices
Location: Remote
Job Type: Contract (W2 / 1099)
Duration: 6+ Months
We are seeking a Senior Product Security Architect with 8+ years of experience to support product cybersecurity and regulatory compliance initiatives for regulated medical devices. The ideal candidate will have strong expertise in FDA cybersecurity requirements , EU MDR , ISO 14971 , IEC 81001-5-1 , AAMI TIR57 , and AAMI SW96 , along with hands-on experience in threat modeling, SBOM, vulnerability management, and PMA/510K cybersecurity documentation .
Responsibilities: Lead product security activities for medical devices in compliance with FDA and EU MDR cybersecurity requirements
Perform STRIDE threat modeling , vulnerability assessments, and security risk analysis
Develop cybersecurity architecture documentation and regulatory security deliverables
Create and maintain SBOMs per NTIA and FDA guidelines
Support PMA / 510K cybersecurity submissions and remediation activities
Utilize SAST, SCA, DAST , and other security tools to improve secure product development
Link cybersecurity risks to safety risks under ISO 14971
Collaborate with Engineering, Regulatory, Quality, and DevOps teams to improve security compliance
8+ years in Product Security / Cybersecurity Engineering
Strong knowledge of FDA cybersecurity , EU MDR , ISO 14971 , IEC 81001-5-1 , AAMI TIR57 , AAMI SW96
Experience with PMA / 510K submissions , SBOM , STRIDE , CVSS , and OWASP Risk Rating
Experience with SAST, SCA, DAST , and vulnerability management tools
Strong documentation and cross-functional communication skills
Experience in medical device cybersecurity architecture
Knowledge of secure SDLC / DevSecOps
Certifications such as CISSP / CSSLP / CEH preferred
Candidates must be authorized to work in the U.S.
Compensation:The hourly rate for this position is competitive and based on experience . ranging From $50-60/hr
Benefits:This is a contract position and does not include employer-provided benefits .
Equal Opportunity Employer:We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:Background checks may be conducted in accordance with applicable law.
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