{"id":1877174,"url":"https://alion.io/job/meridian-bioscience-medical-device-cybersecurity-engineer","title":"Medical Device Cybersecurity Engineer","company":{"id":2303760,"name":"Meridian Bioscience","domain":"meridianbioscience.com","url":"https://alion.io/company/meridianbioscience","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Security","role_family":"Security","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":123000,"max_usd":220000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":340},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"OWASP","optional":false},{"name":"Threat Modeling","optional":false}],"status":"live","first_seen_at":"2026-10-04T22:40:04Z","employer_posted_date":"2026-10-04","last_verified_at":"2026-10-15T04:06:09Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"About Meridian\nMeridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.\nJob Summary\nThe 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.\nKey Duties\nIntegrate cybersecurity requirements into the design and development of software for diagnostic platforms (coding on embedded software)\nEnsure compliance with FDA cybersecurity guidance (pre-market and post-market) and applicable North American regulations\nCollaborate with software development teams to ensure secure-by-design implementation\nTranslate cybersecurity and regulatory requirements into clear technical specifications and documentation\nContribute to and maintain Design History File (DHF) documentation in compliance with design control requirements\nSupport software lifecycle activities aligned with IEC 62304\nParticipate in risk management activities in accordance with ISO 14971 (e.g., threat modeling, risk analysis, mitigation strategies)\nReview system architecture and design to ensure alignment with secure development principles\nAct as a cross-functional liaison between R&D, Quality, Regulatory, and Software Engineering teams\nOther duties as assigned\nTravel 10-15% international travel \nQualifications\nBachelor’s or Master’s degree in Software Engineering, Computer Engineering, or related field\n5 years of experience in software engineering or system-level roles\nRecent experience in cybersecurity, preferably within the medical device or other regulated industry\nStrong understanding of:FDA cybersecurity guidance (pre-market and post-market) \nIEC 62304 software lifecycle processes \nISO 14971 risk management principles \n\nExperience working with regulated design documentation (e.g., DHF, technical files) \nAbility to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams \nExperience with Software and Hardware integration\nStrong collaboration and stakeholder communication skills\nExperience with threat modeling, vulnerability assessment, or security risk management\n Preferred :\nExperience as a Software Lead or Technical Lead capacity \nFamiliarity with Laboratory Information Systems (LIS) and remote device management (IoT) \nKnowledge of additional standards and best practices, such as: \nAAMI TIR57 / TIR97 (Medical device Cybersecurity) \nIEC 81001-5-1 (secure product development lifecycle) \nExposure to secure development frameworks (e.g., NIST Cybersecurity Framework, OWASP) \nBasic knowledge of French or Korean language\n*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. 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