About Spectral MD, Inc.

 

Spectral MD, Inc. is an uptown Dallas based medical tech company that answers clinical questions through the development of data pipelines, artificial intelligence (“AI”) algorithms and proprietary optical technology. Spectral MD Inc.’s DeepView® Wound Imaging System (“DeepView®”) is an advanced medical device that uses a digital approach to deliver images of blood flow under the skin's surface to look deep into the body without ever touching the patient. Our mission is to provide physicians with the ability to accurately assess perfusion and wound healing potential for patients suffering from burn wounds and peripheral artery disease. We are scientists, engineers, and forward-thinkers striving to modernize the management of wound care.  

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Position Overview:

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The Software Analyst at Spectral MD is responsible for the planning, design, documentation, and configuration management of medical imaging device software that incorporates Artificial Intelligence and Machine Learning for medical image analysis. 

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Primary Duties / Responsibilities:

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• Translate clinical requirements and user needs into software development plans as well as software requirements that meet FDA and international regulatory requirements. 

• Work with a cross-functional medical device development team of Human Factors Engineers, Software Engineers, Hardware Engineers, Data Scientists, and Clinical Research Staff to integrate the software requirements into the medical imaging system design. 

• Create and maintain Software Development Plans complying with ISO 62304. 

• Work with Quality Engineering to maintain the Risk Management Plan. 

• Lead the cross-functional team in performing and documenting software risk analysis using techniques such as Hazard Analysis and FMEA to comply with ISO 14971. 

• Develop and design Software Integration and Verification Plans. 

• Design and develop manual and automated software verification tests 

• Analyze and document the software safety classification based on the Risk Analysis 

• Develop and direct software system testing and validation procedures, programming, and documentation. 

• Manage software configurations, documenting the build, release, and customization of software during development as well as on fielded devices. 

• Interface with Quality Engineering as well as Production Engineering to develop software installation and acceptance procedures for cGMP medical device manufacturing. 

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Qualifications:

Required Education and Experience:

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• BS in Computer Science, Engineering, or related field with focus on the software design lifecycle; w/ 

• A minimum of 3 years work experience in the medical device field or other regulated industries. Or 

• MS in Computer Science, Engineering, or related field with focus on the software design lifecycle; w/ 

• A minimum of 1 year experience in medical device field or other regulated industries. 

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Knowledge, Skills, and Abilities:

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• Experience in writing engineering software requirements 

• Solid Knowledge of medical device development standards such as ISO 62304, ISO 13485 and ISO 14971 

• Proficiency in software risk analysis – Software Failure Mode Effect Analysis, Hazard Analysis, Fault Tree Analysis Excellent written communication skills, especially in writing technical manuscripts and software development plans. 

• Fluency in Design Controls that guide the device development process in regulated industries 

• Good understanding in software development lifecycle and the software engineering and development process 

• Experience in software verification, in performing or designing software verification and integration plans, tests, and reports. 

• Familiarity with relevant programming languages such as Python, C#, C/C++. 

• Familiarity with software configuration management. 

• Experience eliciting user needs and translating user needs into design requirements 

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Physical Requirements:

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The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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• Prolonged periods of sitting at a desk and working on a computer

• Must be able to lift, up to 15 pounds at times

 

Travel:

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10% of travel time expected for the position

 

Spectral MD, Inc. is an equal opportunity employer and participates in E-Verify. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other characteristic protected by applicable federal, state, or local laws.