Senior Staff Product Security Engineer - DRE (REMOTE)

Work Flexibility: Remote

Who We Want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What You Will Do:

 Provide leadership and technical guidance regarding DRE product security activities with a focus on Data Security and Privacy, Security Engineering and Security Assurance. Advocate and lead the execution of initiatives and projects to enhance Product Security within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to Stryker policies, regulations, and standards.

Serves as an active member of hub and spoke teams (led by GPOs) to establish, implement, and maintain Global Regulatory and Quality processes and documents in area of responsibility supporting our Global QMS.

Key Areas of Responsibility

• Lead the product security processes for the DRE organization.
• Implement the Stryker Product Security policies in all parts of DRE including Digital, Robotics, Enabling Technologies and AI and ensures compliance with regulations and standards.
• Guide DRE new product development activities on designing Data Security and Privacy requirements into the products to protect patients, customers, and Stryker.
• Consult new product development teams implementing state of the art Security Engineering & Architecture requirements.
• Ensure Product Security support for DRE products pre- and post-market.
• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address product security issues.
• Is initial point of contact and coordinator to Stryker Commercial Divisions for post market security vulnerability investigations and product related security events or incidents including the documentation of vulnerability investigations in the related systems.
• Leads Product Security initiatives or projects.
• Recognized process owner, with expertise across multiple functional areas.
• Provides input into local, global, and corporate processes, represents function on review boards and teams.
• Interpret KPI trends, drive continuous improvement process.
• Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
• Define training requirements on Product Security and provide training.
• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
• Coach and mentor others in Product Security topics and activities.
• Coordinates input, feedback, and represents DRE’s needs.
• Updates the GPO and/or PMO on divisional deliverables and progress.
• Ensures Global initiatives are communicated and understood by DRE stakeholders.
• Travels to hub and spoke meetings.
• Engages in meetings, surveys, information gathering and decisions.
• Delivers against agreed project deadlines.
• Communicates to leadership and stakeholders throughout all levels at DRE.

What You Will Need:

Basic Qualifications:

• Bachelor of Science in product security, computer science, mathematics, statistics, or related field with applicable product security work experience
• 6+ years of related work experience
• Previous experience working in a highly regulated environment

Preferred Qualifications:

• Master’s degree preferred
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Product Security Regulations and Standards.
• Familiarity with ISO 13485, GDP, GMP
• Strong knowledge of Product Security Concepts (e.g. Data Security and Privacy, Security Engineering and Architecture, Security Assurance).
• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
• Ability to represent the Product Securit