Biomedical Product Engineer; Medical Device – Newark, DE or Tarrytown, NY

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Join our team at Siemens Healthineers Diagnostics as a Staff Systems Engineer in the Core Lab Solutions (CLS) R&D System Engineering organization. The Systems Engineering organization is the technical hub for integrating chemistries, mechanics, optics, fluidics, robotics, and control systems to develop and launch new products for the CLS business line. This role will be located in Newark, DE or Tarrytown, NY and reports into the Systems Architecture & Design (SAD).

• Comfortable and adept in Mechanical, Electrical, Fluidic, Thermal, Optical, Low‑Level Real Time Control Firmware, and High‑Level Object‑Oriented Software domains.
• Work with cross‑functional teams (Marketing, Service, Mechanical Engineering, Electrical Mechanical Engineering, Software Engineering, Manufacturing) to develop design concepts for new products.
• Partner with stakeholders to translate Voice of Customer (VoC) inputs, clinical needs, and regulatory standards into actionable use cases and system requirements for the CLS business.
• Oversee usability assessments and Human Factors Engineering throughout the development lifecycle (formative and summative testing).
• Lead safety risk management activities (e.g., Hazard Analysis, FTA, DFMEA) and systematically identify, document, and track system‑level risks.
• Direct the design and execution of laboratory experiments to assess feasibility of medical instrument system, subsystem, and component design concepts.
• Execute subsystem and system design characterization and performance testing to evaluate, debug, and optimize integrated operations.
• Lead the development of instrument features and system integration, resolving subsystem‑to‑subsystem interface issues for seamless hardware–software functionality.
• Conduct trade‑off studies to evaluate and select optimal technical solutions based on cost, performance, and risk.
• Design and develop AI agents that coordinate cross‑functional workflows, enabling intelligent automation and decision support across product development.
• Provide expertise to determine root causes of system/assay performance issues and propose design modifications.
• Collaborate with Structured Testing and Practices (STP) to develop and review testing plans, protocols, and provide troubleshooting and data analysis support.
• Mentor engineers on Model‑Based Systems Engineering and expand use of modeling simulation tools.
• Excel in communication, keeping development teams aligned and presenting information to leadership audiences.

• Master’s or PhD degree in Engineering.
• Significant hands‑on experience with optics, sensors, and imaging systems, emphasizing experimental work and rapid prototyping.
• Extensive development and application experience in an MBSE framework.
• Deep experience in complex electro‑opto‑mechanical instrumentation for medical/imaging applications in new‑product development.
• Extensive experience with the medical device product lifecycle.
• Expert knowledge in Design for Reliability, including reliability requirements allocation, fault‑tolerant systems, and reliability statistics.
• Expert level knowledge of modern design methodologies, code generation, and associated tools (root cause analysis, DFMEA, DOE, ML/AI).
• Demonstrated ability to lead and collaborate with technical teams and drive results.
• Experience working with large cross‑functional multidisciplinary teams in matrixed organizations.
• Expert level knowledge of statistical techniques and Six Sigma methodologies.
• Knowledge and experience in Scrum/Agile product development.

• Bachelor’s degree in biomedical engineering or a related engineering discipline (e.g., optical, mechanical, chemical, electrical, computer, or system engineering).
• Minimum of 8 years of Systems Engineering or Integrated Hardware‑Software Design engineering…