Systems Engineering Professional
Hoffman Estates, IL

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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