Product Security Engineer - Lake Zurich, United States - Planet Pharma

Description

(This is a hybrid 8-month contract, with potential to extend/convert, for candidates local to the Lake Zurich, IL area)

SUMMARY

This role is a hands-on product security engineering position, encompassing various aspects of medical device apheresis instruments and cybersecurity for web application products. The responsibilities include actively engaging in all stages of secure product development, with a particular emphasis on threat modeling, vulnerability analysis, and risk assessment. Additionally, the role may involve contributing to the architectural design process to guarantee that security requirements are met. Furthermore, the role entails supporting the implementation of a comprehensive security testing strategy

PRINCIPAL ACTIVITES

In compliance with September 2023 FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", the following activities will be performed:

• Threat modeling

• Vulnerability analysis and risk estimation

• Risk evaluation

• Vulnerability prioritization

• Security risk control assessment

• Development and execution of security test strategy

• Review product cybersecurity standard operating procedures and provide pragmatic recommendations for continuous process improvements to maintain compliance with global regulatory standards and agency regulations

• Provide cybersecurity guidance to the broader product development team to ensure uniform adherence to industry best practices across all product designs and processes

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

This job position within the Business Unit – Transfusion and Cell Technologies (BU-TCT) hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO Environmental Management System, or EMS) and ISO Occupational Health and Safety Management Systems, or OHSMS).

REQUIREMENTS

• Bachelor's degree in Computer Science, Computer Engineering, Cybersecurity or related Engineering degree

• Experience or in depth knowledge of FDA regulatory requirements for cybersecurity in medical devices

• 5+ years of experience in performing cybersecurity activities

• Experience in application of cybersecurity to embedded medical device software and/or web applications

• Expected to be abreast of rapidly evolving cybersecurity landscape and applicability to medical devices

• Must possess excellent written and verbal communication skills

Pay Range: $80-87/hr

Schedule: Work Schedule: 8:00am-5:00pm, 5 days/week (hybrid 3 days onsite, 2 days remote)