Staff Biomedical Product Engineer (Medical Device) – Newark, DE or Tarrytown, NY

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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Join our team now at Siemens Healthineers Diagnostics as a Staff Systems Engineer in the Core Lab Solutions (CLS) R&D System Engineering organization within the Diagnostics business. The Systems Engineering (SE) organization is the technical hub for integrating the 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) organization within the SE organization. This is a role well suited to an ambitious experienced professional, looking for the next step in their career. We are seeking a Staff Systems Engineer to serve as a technical pillar within the Systems Architecture & Design (SAD) organization. As a senior-level leader, you will be a visionary force in the development of complex, multi-disciplinary analytical medical instrument systems. You will not only contribute to the design of hardware-software integrated electromechanical instruments but will also define the technical roadmap and architectural standards for our next-generation CLS product portfolio.

Responsibilities of a Staff Systems Engineer:

• Comfortable and adept in working in the following primary domains: Mechanical, Electrical, Fluidic, Thermal, Optical, Low-Level Real Time Control Firmware, High-Level Object-Oriented Software.
• Work with cross-functional teams (Marketing, Service, Mechanical Engineering, Electrical Mechanical Engineering, Software Engineering, Manufacturing) in developing design concepts for new products.
• Partner with stakeholders to define Voice of Customer (VoC) inputs, clinical needs, and regulatory standards into clear, actionable use cases and system requirements and specifications for the CLS business.
• Oversee comprehensive Usability Assessments and Human Factors Engineering throughout the development lifecycle (Formative and Summative testing).
• Oversee comprehensive safety risk management activities (e.g., Hazard Analysis, FTA, dFMEA) by systematically identifying, documenting, and tracking system-level risks.
• Oversee the design and execution of laboratory experiments to evaluate feasibility of medical instrument system, subsystem and component design concepts.
• Oversee the execution of subsystem and system design characterization and performance testing to assess, debug, and optimize the integrated operation of complex subsystems.
• Lead the development of instrument features, system integration efforts, assisting cross-functional teams to resolve subsystem to subsystem interface issues and ensure seamless function between hardware and software subsystems.
• Direct trade-off studies and analyses to evaluate and select optimal technical solutions based on cost, performance, and risk.
• Lead the design and development of AI agents that coordinate cross-functional workflows, enabling intelligent automation and streamlined decision support across product development.
• Provide subject matter expertise to determine root cause of system/assay performance issues and propose design modifications.
• You will work closely with Structured Testing and Practices (STP) organization to develop/review testing plans and protocols and provide troubleshooting and data analysis support during execution.
• Mentor other engineers on Model Based Systems Engineering and expand the use of modeling simulation tools within the engineering communities.
• Excel in communication and keeping development teams aligned.
• Excel in presenting information to a leadership audience.
• Excel in creation and analysis of complex models to support effective decision making.

 
Desired skills for success in this role:

• Master’s or PhD degree in Engineering
• This role demands significant hands-on experience with optics, sensors, and imaging systems, emphasizing experimental work, quick prototyping, and laboratory-based development.
• Extensive development and application experience in a MBSE framework
• Extensive systems and design engineering experience in complex electro-opto-mechanical instrumentation for medical/imaging applications in a new product development environment
• Extensive experience with medical device product lifecycle 
• Deep practice in Design for Reliability (reliability requirements allocation, fault-tolerant systems, physics of failure, reliability statistics, reliability modeling and prediction) 
• Expert level knowledge and demonstrated capabilities with modern design methodologies, code generation, and associated tools (e.g., Root cause analysis, dFMEA, Design of Experiment, ML/AI) 
• Demonstrated ability to lead and collaborate with technical teams and drive results and outcomes.
• Experience working with large cross-functional multidisciplinary teams in matrixed organization.
• Expert level knowledge of statistical techniques and/or Six Sigma methodologies 
• Knowledge and experience in Scrum/Agile product development 

Required skills for success in this role:

• Bachelor’s degree in biomedical engineering or similar engineering discipline (ex. Optical, mechanical, chemical, electrical, computer, or system engineering)
• Minimum of 8 years of Systems Engineering, and/or Integrated Hardware-Software Design engineering experience in product development environment (5+ years with advanced degree)
• Minimum of 5 years of experience in Model Based Systems Engineering
• Minimum of 5 years of experience in Modeling/Simulation tools
• Systems Thinking
• Learning mindset
• Critical and clear thinker
• Strong interpersonal and written/verbal communication skills

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Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$131,910 - $181,379

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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