Full-Time
Medical Device Cybersecurity Engineer
Meridian Bioscience
501-1,000 employees
Develops and distributes diagnostic test kits
No salary listed
Remote in USA
Remote
Remote within the US, with 10–15% international travel.
Bachelor's, Master's
 Cybersecurity (1) |
|---|
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- A Bachelor's or Master's degree in Software Engineering, Computer Engineering, or a related field.
- Five years of experience in software engineering or system-level roles.
- Recent experience in cybersecurity, preferably within the medical device or another regulated industry.
- Strong understanding of FDA cybersecurity guidance for pre-market and post-market activities.
- Strong understanding of IEC 62304 software lifecycle processes.
- Strong understanding of ISO 14971 risk management principles.
- Experience working with regulated design documentation, including Design History Files and technical files.
- Ability to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams.
- Experience with software and hardware integration.
- Experience with threat modeling, vulnerability assessment, or security risk management.
- Integrate cybersecurity requirements into the design and development of software for diagnostic platforms, including coding on embedded software.
- Ensure compliance with FDA cybersecurity guidance and applicable North 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 documentation in compliance with design control requirements.
- Support software lifecycle activities aligned with IEC 62304.
- Participate in risk management activities in accordance with ISO 14971, including threat modeling, risk analysis, and 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.
- Travel internationally 10–15% of the time.
- Perform other duties as assigned.
- Experience in a Software Lead or Technical Lead capacity.
- Familiarity with Laboratory Information Systems and remote device management or Internet of Things systems.
- Knowledge of AAMI TIR57 and TIR97 medical device cybersecurity standards.
- Knowledge of IEC 81001-5-1 secure product development lifecycle standard.
- Exposure to secure development frameworks such as the NIST Cybersecurity Framework and Open Worldwide Application Security Project.
Meridian Bioscience develops, manufactures, markets and distributes diagnostic test kits, rare reagents, specialty biologicals and components for life science and agri-bio research. Its diagnostic products are designed for use outside the body with minimal equipment, delivering accurate and fast results to aid early diagnosis of infections and lead poisoning. The company maintains an end-to-end platform from development to distribution and holds strong positions in gastrointestinal and upper respiratory infections as well as blood lead level testing, while its products also serve as components in other diagnostics. Its goal is to improve patient well-being and reduce health care costs by providing accessible, reliable diagnostics and research materials.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Cincinnati, Ohio
Founded
1977
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Simplify's Take
What believers are saying
- Alethia IVDR clearance opens more European hospital and lab purchasing channels in 2026.
- June 26, 2024 lyophilized NGS launch and February 18, 2026 expansion deepen life-science sales.
- New CEO Andy Kitzmiller and CFO Julie Smith, named October 14, 2025, sharpen execution.
What critics are saying
- SD Biosensor and SJL own Meridian since January 31, 2023, limiting employee equity upside.
- October 14, 2025 CEO reset signals pressure to accelerate growth after ownership change.
- 4bases partnership exposes Meridian to partner-dependent commercialization if KaryoSolver adoption stalls.
What makes Meridian Bioscience unique
- Alethia IVDR certification on February 23, 2026 validates broad European molecular assay reach.
- Meridian's lyophilized NGS kits eliminate cold-chain shipping, a rare workflow advantage.
- Health Canada licensed Alethia CMV on July 8, 2026, expanding regulated diagnostics breadth.
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Benefits
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Growth & Insights and Company News
6 month growth
↑ 8%1 year growth
↑ 8%2 year growth
↑ 8%Meridian Bioscience has received Health Canada licensing for its Alethia CMV assay, expanding its molecular diagnostic offerings in the Canadian market. The assay joins Meridian's existing Alethia menu, which includes tests for C. difficile, Group A Strep, Group B Strep, malaria, Mycoplasma, and pertussis. The Alethia platform uses LAMP technology to deliver molecular results in under an hour. The CMV assay enables early detection of congenital cytomegalovirus, which affects one in 200 babies annually. Nearly one in four women carry CMV, the most common congenital infection transmitted during pregnancy. The assay uses saliva samples for congenital CMV testing. Meridian Bioscience is a privately held life science company headquartered in Cincinnati, Ohio, serving customers in over 70 countries.
Meridian Bioscience has partnered with 4bases to enable global deployment of KaryoSolver, a next-generation cytogenetics assay, through advanced reagent stabilisation technology. The collaboration addresses a critical barrier to scaling NGS workflows: the cold-chain requirements of conventional liquid-based library preparation solutions. Meridian's lyophilisation platform stabilises KaryoSolver's NGS library preparation components, enabling ambient-temperature shipping and storage whilst maintaining diagnostic performance. The technology eliminates refrigerated logistics, extends shelf life, and simplifies global distribution. KaryoSolver consolidates structural variant detection into a single assay with integrated analysis, delivering genomic insights within hours versus days for traditional workflows. The stabilisation breakthrough allows 4bases to expand access to comprehensive genetic diagnosis whilst reducing costs and operational complexity across international markets. Both companies will exhibit at the European Human Genetics Conference in Gothenburg this June.
4bases is happy to announce a collaboration agreement with Meridian Bioscience. Ambient-stable NGS workflows, enabled by Meridian's lyophilization expertise, expand global access to 4bases' KaryoSolver(TM), a platform for rapid structural variant analysis. The Life Science division of Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced a collaboration with 4bases SA focused on one critical objective: expanding the accessible market and enhancing the global deployment of KaryoSolver(TM), a next-generation cytogenetics assay, through advanced assay stabilization. KaryoSolver(TM) represents a significant step forward in cytogenetics. Traditional workflows rely on multiple complementary tests, often taking days to deliver a complete picture. In contrast, KaryoSolver(TM) consolidates structural variant detection into a single assay with integrated data analysis, providing actionable genomic insights within hours. However, bringing this innovation to a global market requires overcoming a critical barrier: reagent stability. Conventional liquid-based NGS library preparation solutions are inherently limited by short shelf life, creating significant challenges across the distribution chain, including the cost and complexity of refrigerated shipping and storage that have historically restricted scalable global expansion. Meridian addressed this challenge through its advanced reagent stabilization platform, combining formulation science with optimized enzyme lyophilization technology. By stabilizing the NGS library preparation components, Meridian enabled KaryoSolver(TM) to be shipped and stored at ambient temperatures, eliminating cold-chain requirements, extending shelf life, and simplifying inventory management across the global distribution channels. In addition, lyophilization streamlines manufacturing, supporting more efficient and scalable production. "Our platform technology enabled the transition of the assay into a room-temperature stable format while preserving the performance characteristics required for molecular diagnostics," said Florent Chang-Pi-Hin, Vice President, Research and Development at Meridian Life Science. "By removing cold-chain constraints without sacrificing assay integrity, we're helping expand access to reliable testing worldwide." In this fruitful collaboration, Meridian and 4bases R&D teams joined efforts to optimize Meridian's Lyophilized NGS Enzymatic DNA Fragmentation reagents for the development of a kit to be integratied into 4bases' Oxford Nanopore Technologies workflow, ensuring reliable and efficient sample preparation within the broader assay system. "The idea behind KaryoSolver(TM) is to simplify access to comprehensive genetic diagnosis, and Meridian's expertise in stabilization has been transformative," said Fabio Grandi, COO & Co-Founder at 4bases. "Short shelf life and cold-chain requirements previously limited how far and how efficiently we could scale. With lyophilization, we can now reliably supply our global customers while simplifying logistics, reducing costs, and accelerating the adoption of KaryoSolver(TM) as a rapid, single-workflow solution for cytogenetics." Together, Meridian and 4bases are removing key barriers to advanced genomic testing, pairing breakthrough assay design with the stability, scalability, and operational efficiency required for effective global deployment. 4bases and Meridian Bioscience will both be exhibiting at the upcoming European Human Genetics Conference (ESHG) on June 13-16 in Gothenburg, Sweden, where attendees will have the possibility to learn more about the companies' collaboration and latest advances in ambient-stable next-generation sequencing workflows and cytogenetics solutions. Additional event details, including opportunities to schedule meetings with the Meridian Bioscience and 4bases teams during ESHG, can be found at https://4bases.ch and Meridian Bioscience's events page. Share:
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CINCINNATI, March 6, 2025 /PRNewswire/ -- Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, proudly congratulates Catherine Lufkin, Senior Director, Global Point of Care, on being honored with Pure Earth's 2025 "Force of Nature" Award. This prestigious recognition celebrates her leadership and dedication to advancing environmental health, particularly in the fight against lead poisoning.Lufkin is being recognized at Pure Earth's International Women's Day celebration for her unwavering commitment to ensuring access to fast, accurate blood lead testing in communities impacted by lead contamination. Her leadership has been instrumental in Meridian's partnership with Pure Earth, which has provided LeadCare® II blood lead testing technology to under-resourced communities worldwide since 2016. Her dedication to advancing lead testing was also a driving force behind Meridian winning the CDC's Lead Detect Prize, a prestigious competition that fostered the development of innovative, rapid lead detection technologies to enhance public health efforts."We are immensely proud of Catherine's achievements and this well-deserved recognition," said Tony Serafini-Lamanna, President of Meridian Bioscience Diagnostics. "Her work exemplifies our mission to improve global health through innovation and collaboration. In our ongoing partnership with Pure Earth, we remain committed to reducing lead exposure and its harmful effects on vulnerable populations."The LeadCare II system, the only CLIA-waived point-of-care blood lead testing system, is a vital tool in Pure Earth's global efforts to combat lead poisoning