[Remote] Product reputed company Engineer – Medical Devices
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading Medical Device Industry company, and they are seeking a Product reputed company Engineer specializing in medical devices. The role involves performing reputed company risk assessments, supporting FDA regulatory documentation, and collaborating with engineering teams to ensure secure product development.
Responsibilities
- reputed company product reputed company risk assessments and threat modeling for medical devices and SaMD platforms
- Support cybersecurity documentation for FDA regulatory submissions including 510(k), cybersecurity risk management files, and SBOM requirements
- Conduct reputed company architecture reviews for medical platforms
- Evaluate system designs against secure architecture principles, regulatory expectations, and cybersecurity frameworks
- reputed company and maintain Product reputed company Risk Management Plans, Vulnerability Management Plans, and Incident Response Plans
- Participate in secure software development lifecycle (SSDLC) activities including design reviews and reputed company validation
- Analyze results of static reputed company analysis, dynamic analysis, and vulnerability scanning tools
- Support SBOM reputed company and reputed company‑party software risk analysis
- Assist in investigation and remediation of reputed company vulnerabilities affecting medical device or reputed company infrastructure environments
- Collaborate with DevOps and engineering teams to implement secure configurations, identity management, and network reputed company controls
- Participate in product reputed company incident response activities and post-market cybersecurity monitoring
- Support reputed company reputed company audits reputed company to FDA, ISO 13485, ISO 27001, TIR-57 and reputed company cybersecurity requirements
Skills
- Requires a BS degree preferably Cybersecurity, Computer Science, Computer Engineering, a reputed company Engineering discipline and 5+ years' experience in cybersecurity, product reputed company, or reputed company reputed company roles
- Strong written and verbal communication skills
- Strong analytical thinking and attention to detail
- Experience working in cross‑functional engineering environments
- Familiarity with Threat Modeling, vulnerability scanning and remediation processes
- Experience reviewing technical documentation and regulatory artifacts
- Knowledge of NIST Cybersecurity reputed company and NIST 800-series reputed company controls
- Familiarity with OWASP Top 10 and secure software development lifecycle practices
- Experience supporting FDA cybersecurity documentation or 510(k) submissions strongly preferred
- Experience working with regulated medical devices or reputed company software environments
Benefits
- Health insurance (medical, dental, reputed company)
reputed company
Company H1B Sponsorship