Experience: 12+ Years
Job Description:
We are searching for top talent for Lead Product Security Engineer. The preferred locations for this role are San Jose, California; Cincinnati, Ohio; and Raritan, New Jersey. Remote opportunities in the US are available on a case by case basis and if approved by the company. This role may require up to 10 - 20% travel.
The Lead Medical Device Cybersecurity Engineer will be responsible for implementation of the customer''''s enterprise Product Security strategy and framework for the customer''''s MedTech Surgery Ottava Robotic Platform. This includes identifying key strategy and goals, collaborating with internal organizations on existing process and policy enhancements, creating and communicating metrics to Ottava management, identifying communications plans and raising overall awareness of the capability.
Specific responsibilities include supporting Ottava’s R&D throughout a new product’s development phases, review product security requirements and recommend security design solutions, ensure the team completes Quality documentation, threat modelling, security risk assessment, penetration testing, software architecture review and design recommendations, code analysis and other security testing or work as needed.
Additionally, post market responsibilities for Ottava’s surgical robotic platform marketed devices include monitoring for new vulnerabilities, leading the product security teams with patching and remediation plans, as well as responding to all customer security questionnaires and reviewing security language within contractual agreements.
Key Responsibilities:
Help drive adherence to the customer''''s Product Security’s overarching framework
Partner with internal organizations to enhance existing processes and policies
Create and present Product Security metrics to management within Ottava and ISRM
Champion Product Security strategy and objectives across the Ottava Robotic Platform
Engaged as a subject matter expert to support completion of product security activities, tasks, deliverables, documentation, approvals, and product security controls.
Responsible for defining security requirements for the product and associated applications
Responsible for reviewing the Threat Model and Security Risk Assessment in collaboration with Systems Engineering.
Responsible for supporting the FDA pre-market cybersecurity documents (as needed) and collaborating with regulatory compliance stakeholders and activities.
Responsible for the facilitation and assessing any third parties’ penetration testing and/or validation services.
Perform regular reviews and analysis of security reports and issues, propose solutions where appropriate and lead their remediation.
Respond to alerts, security incidents, and assist in remediation as needed.
Respond to customer cybersecurity questionnaires for all post-market medical devices.
Other MedTech cybersecurity related duties as needed
Qualifications:
Required:
At least 5 years IT or cybersecurity experience and at least 2 years of product security experience
Bachelor’s degree or equivalent experience
Understanding of penetration testing, vulnerability scanning, CVSS and/or other general security testing principles
Ability to provide secure coding recommendations
Knowledge in at least one coding language (i.e. C/C++, C#, Python) with code review experience highly preferred
Ability to work autonomously and proactively seek out security opportunities within the different surgical robotics teams
Knowledge of traditional and real-time operating systems (i.e. QNX, Windows Embedded, Ubuntu, Yocto) hardening techniques
Ability to translate technical security requirements into solutions
Creative problem-solving skills
Customer focus (internal & external)
Excellent communication and collaboration skills
Preferred Skills:
Understanding of Quality Design Control processes and FDA submission processes.
Hands-on experience with software security tools and platforms like Checkmarx, Black Duck, Jfrog Xray, etc.
Hands-on experience with vulnerability assessment tools.
Knowledge of product or medical device security or MDDS platforms.
Working knowledge of microservices architecture and API security.
Experience working within Agile methodology.
Software development experience
Experience leading or participating in formal security audits (i.e. HITRUST, SOC2, FedRAMP)
Security certification like CISSP/ AWS Security Specialist/ CEH or CSSLP a strong plus.