Alcon-posted over 1 year ago
$132,560 - $198,840/Yr
Full-time • Senior
Lake Forest, CA
Miscellaneous Manufacturing

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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 combination products. This role involves working closely with Research and Development (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. The architect will possess a blend of business and technical know-how to mature product security architecture, software, and solutions engineering functions. They must be able to handle the ambiguity and complexity of customer products, including intended use, interoperability, product architectures, and industry best practices. The architect is expected to be knowledgeable in key aspects of Alcon products, software development, product security processes, agile methods, and overall project execution and management. This position requires a proactive approach to security, ensuring that security is integrated into the product lifecycle from design through deployment and updates. The architect will also be responsible for defining and leading security solutions that meet global product needs and commercial expectations, while supporting product integration with various solutions including lab set-up, proof of concept, feasibility, and MVP realizations. Additionally, the architect will conduct risk assessments and vulnerability analyses to identify potential security threats, developing and implementing strategies to mitigate these risks. Compliance with relevant national and international regulations and standards, such as HIPAA, FDA guidelines for medical devices, and the EU's Medical Device Regulation (MDR), is crucial. The architect will implement and manage security standards, protocols, encryption, and authentication mechanisms to ensure the confidentiality, integrity, and availability of devices. Collaboration with product management, engineering, and external stakeholders to define security requirements is essential, as is staying abreast of the latest security trends, threats, and technologies in the medical device sector to recommend innovative security tools and technologies to enhance product security.

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