Job Description

Job Title: Product Engineer IV/ Product Security Solutions Engineering Architect

Location: Lake Forest, CA - onsite

Contract Length: 12 months with potential to extend.

Product Security Solutions Engineering Architect

• 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 Alcon achieve business objectives and customer needs.
• Here's a detailed job description for a Product Security Solutions Architect specializing in medical devices:

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 Alcon product, software development, product security processes, agile methods, and overall project execution and management.

Key Responsibilities:-

• Security Architecture Design: Develop and maintain a secure architecture for medical device products, ensuring that security is integrated into the product lifecycle from design through deployment and updates.
• Risk Management: Conduct risk assessments and vulnerability analysis to identify potential security threats. Develop and implement strategies to mitigate these risks.
• 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 Protocols: Implement and manage security protocols, encryption, and authentication mechanisms to protect sensitive data.
• Stakeholder Collaboration: Work with product management, engineering, and external stakeholders to define security requirements and ensure that products meet these specifications.
• Training and Advocacy: Promote security awareness and best practices within the organization. Provide training to engineering and product teams on security-related topics.
• 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.

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.

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, Paython, 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/risk

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