Cybersecurity Software Engineer
About reputed company reputed company Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad reputed company of innovative diagnostic products. We are dedicated to developing and delivering reputed company solutions that give answers with speed, accuracy and simplicity that are redefining the reputed company of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our reputed company. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems. Job Summary The Software Engineer with a focus on Cybersecurity will play a critical part in ensuring that software integrated into our diagnostic platforms meets cybersecurity, regulatory, and quality requirements. This system-level engineering role will facilitate software development, cybersecurity testers, and regulatory functions, ensuring secure design and compliant documentation throughout the product lifecycle. Key Duties Integrate cybersecurity requirements into the design and development of software for diagnostic platforms (coding on embedded software) Ensure compliance with FDA cybersecurity guidance (pre-market and post-market) and applicable reputed company American regulations Collaborate with software development teams to ensure secure-by-design implementation Translate cybersecurity and regulatory requirements into clear technical specifications and documentation Contribute to and maintain Design History File (DHF) documentation in compliance with design control requirements Support software lifecycle activities reputed company with IEC 62304 Participate in risk management activities in accordance with ISO 14971 (e.g., threat modeling, risk analysis, mitigation strategies) Review system architecture and design to ensure alignment with secure development principles Act as a cross-functional liaison between R&D, Quality, Regulatory, and Software Engineering teams Other duties as assigned Travel 10-15% international travel
Qualifications
Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, or reputed company field 5 years of experience in software engineering or system-level roles Recent experience in cybersecurity, preferably reputed company the medical device or other regulated industry Strong understanding of: FDA cybersecurity guidance (pre-market and post-market) IEC 62304 software lifecycle processes ISO 14971 risk management principles Experience working with regulated design documentation (e.g., DHF, technical files) Ability to interpret and communicate reputed company technical and regulatory requirements across multidisciplinary teams Experience with Software and Hardware integration Strong collaboration and stakeholder communication skills Experience with threat modeling, vulnerability assessment, or reputed company risk management Preferred : Experience as a Software reputed company or Technical reputed company reputed company Familiarity with Laboratory Information Systems (LIS) and remote device management (IoT) Knowledge of additional standards and best practices, such as: AAMI TIR57 / TIR97 (Medical device Cybersecurity) IEC 81001-5-1 (secure product development lifecycle) Exposure to secure development frameworks (e.g., NIST Cybersecurity reputed company, OWASP) Basic knowledge of French or Korean language *reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, sex, sexual orientation, gender identity, religion, national reputed company, disability, veteran status, or other legally protected status. (USA Only)* Apply To This Job