Systems Engineering Professional

Job Description

Organization: Siemens Healthineers
Business Unit: Diagnostic Imaging
Requisition Number: 245089
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%

Job Description:

The Molecular Imaging (MI) division of Siemens Healthcare (Hoffman Estates, IL facility) is currently seeking a Staff-level Systems Engineer to join our SPECT engineering team to develop the next generation of molecular imaging devices (http://healthcare.siemens.com/molecular-imaging). The ideal candidate should have experience in product requirements analysis, complex system design, and integration of advanced hardware and software systems. This position will work across a cross-functional organization with large and diverse teams, acting in a technical leadership role. The primary function of this role will include the elicitation and elaboration of requirements for molecular imaging devices. A deep understanding of clinical and system level use cases and workflows is needed to develop high-value and novel customer solutions, and a strong background in software design and hardware integration is required to translate new features into system functionality.  A passion for delivering products that improve the outcomes of patient healthcare is essential for membership on our team.


Responsibilities

 

·        Maintain ultimate ownership for the realization of new system functionality over the course of a development project

·        Elicit high quality system requirements from clinical, service, manufacturing, marketing, and other users/stakeholders

·        Elaborate and decompose user and system level requirements into detailed and complete specifications

·        Write and drive engineering level compliance requirements, specifications, verification testing protocols and product certifications in accordance with IEC, ISO, US FDA, EU Medical Devices Directives, CE, UL, etc.

·        Identify, quantify, and drive the mitigation of technical risks to our projects and products

·        Champion both the extrinsic quality (proven by functional verification) and the intrinsic quality (proven by clinical validation) of our products

·        Productize cutting-edge technologies to deliver breakthrough medical care to our customers and patients

·        Ensure seamless integration of complex hardware and software subsystems that are designed and manufactured at multiple locations across the globe



Required Knowledge/Skills, Education, and Experience

 

·        Extensive (5+ years) experience with product analysis and requirements engineering

·        Strong background in hardware and software design

·        Deep understanding of clinical diagnostic imaging use cases and workflows

·        Bachelor degree or greater in Systems Engineering, Biomedical Engineering, Computer Science, Electrical Engineering , Mechanical Engineering or related field

·        8+ years of direct engineering experience with complex products

·        Strong interpersonal, written and verbal communication skills to convey ideas and concepts to a wide range of international audiences (USA, Germany, China & India) including the clinical community, product management and other engineers

·        Positive attitude team player with ability to also work autonomously

·        Ability to work in a fast-paced, deadline-oriented environment

·        Domestic and international travel required periodically (< 5%)



Preferred Knowledge/Skills, Education, and Experience

 

·        Comprehensive knowledge of system design principles

·        Hands-on experience with integration of complex software and hardware systems

·        Understanding and knowledge of typical regulatory requirements, international regulatory issues, industry best practices and certification processes.

·        Demonstrates the ability to manage change in rapidly evolving situations

·        Exhibits skills needed to bridge gaps between technical and non-technical stakeholders

·        Experience with developing and executing system level verification tests

·        Experience with performing safety risk analyses

·        Advanced technical or business degree

·        Solid understanding of medical physics as it relates to system performance

·        Experience with 510K medical devices or other highly regulated environments


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