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Responsibilities:
- Integrate cybersecurity requirements into design and development of diagnostic platform software.
- Ensure compliance with FDA cybersecurity guidance and North American regulations.
- Contribute to Design History File documentation and design control.
Qualifications:
- Bachelor's or Master's in Software Engineering, Computer Engineering, or related field.
- 5+ years software engineering or system-level experience.
- Strong understanding of FDA cybersecurity guidance, IEC 62304, ISO 14971.
Preferred Experience:
- Experience as a Software Lead or Technical Lead.
- Familiarity with Laboratory Information Systems (LIS) and remote device management (IoT).
- Knowledge of AAMI TIR57/TIR97, IEC 81001-5-1, NIST Cybersecurity Framework, OWASP.
Meridian Bioscience, Inc.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes innovative diagnostic products. We are dedicated to redefining the possibilities of life from discovery to diagnosis with a collaborative culture seeking talented individuals.