Systems Engineer

1 month ago

Dallas, United States Spectral MD Inc Full time
Job DescriptionJob Description

The Systems Engineer Role at Spectral MD is a cross-functional partner of engineering peers in Software, Optics, Electrical, Mechanical, Biomedical and Data Science teams. The Systems Engineer orchestrates the architecture and integration of an AI/ML driven Diagnostic Imaging Medical Device. The Systems Engineer plays a key role in delivering the System Requirements, driving system design decisions, performing the Risk Analysis, and planning and tracing the System Verification and Validation. The role is primarily focused on new product research and development.

Essential Duties and Responsibilities:

  • Gather/elicit customer needs from different stakeholders and translate them into system design, system requirements, and sub-system requirements that form the basis of system validation.
  • Develop System Requirements and their tracing to sub-system requirements throughout the entire development project lifecycle
  • Work across all engineering functions (Optics, Electrical, Mechanical, Biomedical, Software, Data Science) to ensure there is a shared understanding of the system architecture and goals.
  • Plan for the Verification and Validation of the system requirements and user needs for the integrated system.
  • Create and maintain traceability among user needs, system, sub-system level requirements and risk management artifacts to ensure completeness and fully traceable design history file.
  • Plan and develop system level testing to ensure sub-systems maintain performance when integrated
  • Own the Risk Analysis process to meet ISO 14791 requirements, including Hazard Analysis, FMEA, management and tracing of risk controls, and planning and tracing of verification and validation of risks.
  • Responsible for the following minimum deliverables:
    1. Requirements Analysis, User Needs, System Requirements, Subsystem Requirements
    2. Risk Analysis, Preliminary Hazard Analysis, Device Hazard Analysis, FMEAs (e.g. software, use, design)
    3. Traceability Matrix
    4. System Integration planning
  • After subsystem verification, systems engineering supports the integration of subsystems, the final system evaluation and transfer to manufacturing

Qualifications:

Required education and experience:

  • Bachelor of Science (M.S. preferred) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent, including relevant coursework and/or work experience in product development.
  • 3+ years of experience in complex product development (comprising electro-mechanical and software pieces), preferably in a fast-paced, medical device design environment.
  • Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, EU MDR).
  • Ability to lead engineering discussions on requirements and risk, and work as a bridge among different engineering departments and global stakeholders.
  • Experience allocating requirements across multiple subsystems.
  • Experience with Hazard Analysis (HA), and Failure Mode and Effect Analysis (FMEA).
  • Ability to effectively communicate, convey and exchange information with engineering peers.
  • Strong written, verbal, interpersonal, documentation and presentation skills.
  • Driven to be solution oriented. Always seeking opportunities to resolve issues in a timely and effective manner.

Knowledge, Skills and Abilities:

  • Thorough understanding of requirements management; from user needs through verification and validation; experience with requirements management tools.
  • Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, and FMEA.
  • Experience in the development of system architectures.
  • Working knowledge of safety compliance process (product safety marks).
  • Experience in the conduct of design verification activities.
  • A minimum of 2 years of this experience in a SE role while operating under a quality system (e.g., ISO 13485)

Physical Requirements:

  • Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
  • Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
  • Occasionally work around moving mechanical parts.

Travel:

  • 10% as needed to visit clinical sites to interact with users and observe procedures


Equal Employment Opportunity:

Spectral MD, Inc. is an equal opportunity and affirmative action employer. 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, protected veteran status, or any other characteristic protected by applicable federal, state or local laws.

  • Windows System Engineer

    1 week ago

    Dallas, United States Vertex Computer Systems Full time

    Are you a Azure System EngineerIf so, check out this job !Vertex is a US-based tech company with 15 years’ experience in Microsoft, Salesforce, BI, AI, and Cloud Computing. We have earned longstanding client relationships as trusted, long-term partners. Every day we inspire, innovate, and implement solutions that solve complex business problems using...

  • Windows System Engineer

    3 weeks ago

    Dallas, United States Vertex Computer Systems Full time

    Are you a Azure System EngineerIf so, check out this job !Vertex is a US-based tech company with 15 years’ experience in Microsoft, Salesforce, BI, AI, and Cloud Computing. We have earned longstanding client relationships as trusted, long-term partners. Every day we inspire, innovate, and implement solutions that solve complex business problems using...

  • Senior Engineer in Control Systems

    6 days ago

    Dallas, Texas, United States Slate River Systems Inc Full time

    Job OverviewThe Senior Engineer in Control Systems at Slate River Systems Inc. will be responsible for the design and execution of material handling equipment (MHE) control systems. These systems can range in complexity and may encompass various components, including but not limited to: Pallet Conveyors, Case Conveyors, Sortation Systems, Automated Storage...

  • Senior Controls Systems Engineer

    16 hours ago

    Dallas, Texas, United States Slate River Systems Inc Full time

    Job SummaryThe Senior Controls Systems Engineer will be responsible for designing and implementing controls systems for various MHE applications, including pallet conveyor, case conveyor, sortation, ASRS and AGVs control, and interface with WCS, RCS, and SCADA systems.Key ResponsibilitiesDevelop standard controls hardware offerings, including electrical...

  • Sr Controls Systems Engineer

    3 months ago

    Dallas, United States Slate River Systems Inc Full time

    Job DescriptionJob DescriptionDescription:The Slate River Systems’ Senior Controls Systems Engineer will design and implement MHE controls systems. These systems vary in complexity and scope and may include, but are not limited to: Pallet Conveyor, Case Conveyor, Sortation, ASRS and AGVs control, and may interface with Warehouse Control Systems (WCS),...

  • System Engineer

    3 weeks ago

    Dallas, United States Cinter Career Services, LLC Full time

    We are seeking a skilled System Engineer to join our dynamic IT team in Dallas, TX. As a System Engineer, you will be responsible for designing, implementing, and maintaining enterprise systems and applications. You will collaborate closely with various teams to ensure the reliability, scalability, and security of our systems infrastructure. Working...

  • System Engineer

    3 weeks ago

    Dallas, United States Cinter Career Full time

    Job DescriptionJob DescriptionWe are seeking a skilled System Engineer to join our dynamic IT team in Dallas, TX. As a System Engineer, you will be responsible for designing, implementing, and maintaining enterprise systems and applications. You will collaborate closely with various teams to ensure the reliability, scalability, and security of our systems...

  • Mansion Overnight Maintenance Engineer

    2 weeks ago

    Dallas-Fort Worth Metroplex, United States Overnight Maintenance Engineer Full time

    Job summary - • Overlook plumbing systems for the hotel repairs and replace defective components. To overlook all electrical systems of the hotel. To maintain, repair all hotel furniture including public areas up to required standards. Build simple furniture as per specifications and design. To respond to all repair calls from guests and other...

  • System Engineer

    2 months ago

    Dallas, United States CornerStone Technology Talent Services Full time

    Systems EngineerLocation: Addison, TX Type: Hybrid, Contract to Hire Schedule: 13-week contract to hire, full time 40hr per week About the Role:CornerStone Technology Talent Services is looking for a talented Systems Engineer for an excellent hybrid opportunity in Addison, Texas. The ideal candidate will have a strong background in VMware, NetApp, Microsoft...

  • System Engineer

    2 weeks ago

    Dallas, United States InRhythm Full time

    We are looking for a System Engineer : As a System Engineer, you will work with lead-level and senior-level engineers designing, testing, and integrating complex systems and troubleshooting problems that arise.At InRhythm, you will: Work on a high-velocity scrum teamWork with clients to come up with solutions to real-world problemsArchitect and implement...

  • System Engineer

    2 weeks ago

    Dallas, United States InRhythm Full time

    We are looking for a System Engineer : As a System Engineer, you will work with lead-level and senior-level engineers designing, testing, and integrating complex systems and troubleshooting problems that arise.At InRhythm, you will: Work on a high-velocity scrum teamWork with clients to come up with solutions to real-world problemsArchitect and implement...

  • System Engineer

    2 weeks ago

    Dallas, United States InRhythm Full time

    We are looking for a System Engineer: As a System Engineer, you will work with lead-level and senior-level engineers designing, testing, and integrating complex systems and troubleshooting problems that arise. At InRhythm, you will: Work on a high-velocity scrum teamWork with clients to come up with solutions to real-world problemsArchitect and implement...

  • Systems Engineer

    1 week ago

    Dallas, United States Motion Recruitment Full time

    Job Description Our client, a company that specializes in automotive insurance, is looking for a Systems Engineer in Dallas, Tx (Oaklawn area). Right now, they need a Systems Engineer to join their team to design, deploy, support, and maintain servers, storage, operating systems, and applications in production and pre-production environments. It involves...

  • Refractory Systems Engineer

    1 month ago

    Dallas, United States Cornerstone TTS Full time

    CornerStone Technology Talent Services is hiring a Refractory Systems Engineer for our client. This permanent, full-time role is available for USC/Green Card candidates in the Dallas-Fort Worth area. Job Description: As a Refractory Systems Engineer, you will design, analyze, and maintain refractory systems within a complex environment that includes...

  • Refractory Systems Engineer

    1 month ago

    Dallas, United States Cornerstone TTS Full time

    CornerStone Technology Talent Services is hiring a Refractory Systems Engineer for our client. This permanent, full-time role is available for USC/Green Card candidates in the Dallas-Fort Worth area. Job Description: As a Refractory Systems Engineer, you will design, analyze, and maintain refractory systems within a complex environment that includes...

  • Refractory Systems Engineer

    1 month ago

    Dallas, United States Cornerstone TTS Full time

    CornerStone Technology Talent Services is hiring a Refractory Systems Engineer for our client. This permanent, full-time role is available for USC/Green Card candidates in the Dallas-Fort Worth area. Job Description: As a Refractory Systems Engineer, you will design, analyze, and maintain refractory systems within a complex environment that includes...

  • Lead Systems Engineer

    2 days ago

    Dallas, Texas, United States Cleaver-Brooks Sales and Service, Inc. Full time

    Lead Systems Engineer at Cleaver Brooks Sales and ServiceCleaver Brooks Sales and Service is in search of a Lead Systems Engineer to enhance our team. The successful candidate will have a robust background in the boiler sector, with a minimum of eight years of experience in the design, construction, installation, and operation of boiler systems. The Lead...

  • Enterprise Systems Engineer

    5 days ago

    Dallas, Texas, United States Fortinet Full time

    Position: Enterprise Systems EngineerObjective:We are seeking a dedicated Enterprise Systems Engineer to collaborate closely with a Named Account Manager within a designated region. The primary role of the Systems Engineer will be to provide comprehensive technical support to the sales team throughout the sales process, including pre-sales, sales...

  • Transportation Systems Engineer

    6 days ago

    Dallas, Texas, United States HDR Full time

    About HDR HDR is a leader in engineering, architecture, environmental, and construction services. We are renowned for enhancing communities through innovative buildings and intelligent infrastructure, but our expertise extends far beyond that. Our multidisciplinary teams consist of scientists, economists, builders, analysts, and artists, all contributing to...

  • Facility Systems Engineer

    9 hours ago

    Dallas, Texas, United States ABM Industries Full time

    Company Overview:ABM Industries is a prominent provider of integrated facility solutions, dedicated to delivering exceptional service across various sectors.Position Summary:The Building Engineer plays a crucial role in assisting the management with the daily functionality of all building systems. Responsibilities encompass maintenance and repair of hard...