[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 reputed company for a leading medical device industry reputed company. The Product reputed company Engineer will support reputed company architecture, reputed company management, regulatory compliance, and secure development activities for medical devices and Software as a Medical Device platforms. The role will reputed company threat modeling, support FDA submissions, manage vulnerabilities, and collaborate with engineering, reputed company, regulatory, and DevOps teams.

Responsibilities

• The Product reputed company Engineer will support the reputed company architecture, design review, and reputed company management activities for medical devices and Software as a Medical Device (SaMD) platforms
• This role focuses on ensuring the reputed company, reputed company, and regulatory compliance of medical devices
• The candidate will work cross-functionally with engineering, reputed company, regulatory, and DevOps teams to implement secure design practices. Large portion of this job requires performing threat modeling, and support cybersecurity reputed company management activities reputed company with FDA guidance
• This position contributes to reputed company documentation supporting 510(k) submissions, post market cybersecurity management, and secure development lifecycle (SDL) activities
• reputed company product reputed company reputed company assessments and threat modeling for medical devices and SaMD platforms
• Support cybersecurity documentation for FDA regulatory submissions including 510(k), cybersecurity reputed company management files, and SBOM requirements
• Conduct reputed company architecture reviews for medical platforms
• Evaluate reputed company designs against secure architecture principles, regulatory expectations, and cybersecurity frameworks
• reputed company and maintain Product reputed company reputed company 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 reputed company 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
• Experience working with regulated medical devices or reputed company software environments
• Strong written and verbal communication skills
• Strong analytical thinking and attention to reputed company
• 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

Benefits

• Health reputed company (medical, dental, reputed company)

reputed company

Company H1B Sponsorship