Product Security Solutions Engineering Architect

3 weeks ago

Lake Forest, United States Resolution Technologies, Inc. Full time

Product Security Solutions Engineering Architect Job Description:

A Product Security Solutions Engineering Architect for medical devices plays a critical role in ensuring the security of customer products including medical software, hardware, and digital products. This position involves a mix of technical expertise, understanding of healthcare/medical devices regulations, and the ability to design secure systems and recommend solutions to help achieve business objectives and customer needs.


Product Security Solutions Engineering Architect Summary:

The Product Security Solutions Architect will be responsible for leading the design and implementation of security measures for medical device software, hardware, digital solutions and/or combinations products.


This role involves working closely with R&D, product management, regulatory, quality and compliance teams to ensure that all products meet the highest standards of security and privacy in line with regulatory and customer requirements.


This person possesses blend of business and technical know-how to mature product security architecture, software and solutions engineering function; Able to handle ambiguity and complexity of customer products including intended use, interoperability, product architectures and industry best practices.


The architect is knowledgeable in key aspects of product, software development, product security processes, agile methods, and overall project execution and management.


Product Security Solutions Engineering Architect Key Responsibilities:

  • Security Architecture Design: Develop and maintain a reference secure architecture for medical device products, ensuring that security is integrated into the product lifecycle from design through deployment and updates.
  • Implement Security Solutions: Define and lead security solutions that are needed for global products and meet customer needs and commercial expectations.
  • Security Integration Management: Support product integration with various solutions including lab setup, proof of concept, feasibility and MVP realizations and ensure interoperability of security capabilities
  • Risk Management: Conduct risk assessments and vulnerability analysis to identify potential security threats. Develop and implement strategies to mitigate these risks with common solutions and design.
  • Compliance and Regulations: Ensure that all medical device products comply with relevant national and international regulations and standards, such as HIPAA, FDA guidelines for medical devices, and the EU’s Medical Device Regulation (MDR).
  • Security Standards and protocols: Implement and manage security standards, protocols, encryption, and authentication mechanisms and other implementations to ensure confidentiality, integrity and availability of devices.
  • Stakeholder Collaboration: Work with product management, engineering, and external stakeholders to define security requirements and ensure that products meet these specifications.
  • Innovation and Research: Stay abreast of the latest security trends, threats, and technologies in the medical device sector. Recommend innovative security tools and technologies to enhance product security.


Product Security Solutions Engineering Architect Qualifications:

• Bachelor’s or master’s degree in computer science, Information Security, or a related field.

• Professional certifications in information security (e.g., CISSP, CISM) are highly desirable.

• Extensive experience in product security, particularly in the design and implementation of security solutions for medical devices or related healthcare technology.

• Deep understanding of healthcare regulations and standards affecting medical device security.

• Proficiency in security architectures, encryption technologies, identity and access and network security etc.

• Experience with risk management methodologies and security assessment tools.

• Strong analytical and problem-solving skills.

• Product security processes, tools and techniques especially implementation aspects.

• Excellent communication and interpersonal skills, with the ability to explain complex security concepts to non-technical stakeholders.


Product Security Solutions Engineering Architect Preferred Qualifications:

• Knowledge in reference architecture and design patterns as applicable to medical technologies and products

• Working knowledge in Software engineering and programming languages (Java, Python, C/C++/C# etc.)

• Implementation and adoptions of security frameworks such as SABSA/TOGAF frameworks

• Emerging medical technologies (AI, Blockchain, MIoT, RPA, etc.) and their security threats/risks

• Knowledge of medical integration standards, including HL7, DICOM, EHR, and FHIR.

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