Principal Engineer (Associate Director)

Irvine, CA 92602

Posted: 09/09/2023 Job Category: Java Architect Job Number: 2771

Job Description

Principal Engineer (Associate Director)

Principal Engineer (Associate Director) Job Description:
  • The Associate Director, Product Security Lifecycle will be supporting Global Research & Development Product Development. You will be responsible for leading all aspects of and managing the end-to-end Product Security Lifecycle efforts from strategy, developing, and implementing product security processes for medical devices and digital solutions. A key aspect of this role is to manage and ensure products comply with the cybersecurity pre-market and post-market activities and to support governance, compliance, and risk management initiatives. In this role, a typical day will include:
  • Manage overall governance, compliance, and risk management processes for the product security and privacy program
  • Manage and sustain the Product Security Process (PSP) and related policies, procedure and standards, and other internal company standard operating procedures (SOPs).
  • Simplify as relevant the PSP processes and procedures and ensure continuous security enablement with global regulatory requirements and frameworks.
  • Enable product security post-market processes (operations, incident management, change management processes, etc.). Facilitate and lead where relevant the product security audits, third party assessment, and compliance initiatives and meet internal stakeholder requirements (HIPAA, UL 2900, and Quality, Regulatory, etc.).
  • Lead global product security engagement in meeting registration filing needs working closely with regulatory teams.
  • Ensure consistency across customer security documentation as needed.
  • Develop internal and external product security materials including training and awareness, product-specific materials, security guides, labeling needs, and other technical materials.
  • Collaborate with company cross-functional team to support process improvements and automation as needed including common artifacts, tools implementation, security portals, etc.
  • Building capabilities, tools, including automation to drive improvements for company product security process and practices.
  • Providing guidance and training to product development teams on product security best practices and processes. Staying up to date with the latest global product security standards, frameworks, and global regulations
  • Support quantification of security/privacy risks and readouts to senior leadership.

Principal Engineer (Associate Director) Minimum Qualifications:
  • Bachelor’s Degree or equivalent years of directly related experience
  • The ability to fluently read, write, understand, and communicate in English.
  • 5+ Years of Relevant Experience in cybersecurity processes, frameworks, regulations (FDA/MDR/HIPAA etc.)
  • Working knowledge in cybersecurity processes, frameworks, regulations and product/software development process, agile processes, etc.
  • Demonstrated ability to communicate and collaborate effectively with Global teams.
Principal Engineer (Associate Director) Preferred Skills:
  • Industry experience in a regulated environment. Preferred to have a Medical Device, MedTech, or health care experience.
  • Experience in the delivery and execution of product security processes, standards, best practices, and tools.
  • Application of global privacy compliance, security regulations across software development lifecycle. Creative ways to apply process management best practices to enable teams to operate more efficiently.
  • Experience in program/project management in cybersecurity initiatives.

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Job Requirements

DICOM, HL7, EMS, Cybersecurity, Cloud, Platform, Design, Architecture, Java, Angular, React, NodeJS, AWS, Kubernetes, Docker

Meet Your Recruiter

Sam Slonkosky
Technical Recruiter

I'm happy to connect with you on your next career challenge. Whatever your needs are, we at Resolution Technologies promise to provide unrivaled quality and service. Please don't hesitate to contact me if you have any questions about this position.

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