What are the responsibilities and job description for the Senior Systems Engineer position at Spectral AI?
Position Summary
The Senior Systems Engineer Role at Spectral AI 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 a AI/ML driven Medical Diagnostic Imaging Device. The Senior 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
Required education and experience:
Spectral AI, 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.
The Senior Systems Engineer Role at Spectral AI 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 a AI/ML driven Medical Diagnostic Imaging Device. The Senior 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 user/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, Algorithm) to ensure there is a shared understanding of the system architecture and goals.
- Oversee the integration and testing of sub-systems into the complete system to meet system requirements
- 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
- Skilled in developing and validating test methods to ensure reliable results
- Manage and own activities as related to Risk Management in accordance to ISO 14971,
- Drive efforts in gathering the necessary data to maintain an effective Risk Management File by updates 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:
- Requirements Analysis, User Needs, System Requirements, Subsystem Requirements
- Risk Analysis, Preliminary Hazard Analysis, Device Hazard Analysis, FMEAs
- Traceability Matrix
- System Integration planning
Required education and experience:
- Bachelor of Science (M.S. preferred) in Biomedical Engineering, Electrical Engineering, or equivalent, including relevant coursework and/or work experience in product development.
- 5 years of experience in product development
- Experience developing Class II and/or Class III medical devices.
- Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
- Expert level requirement elicitation, analysis and documentation skills.
- Ability to moderate requirements engineering discussions and work as a bridge among different engineering departments and global stakeholders.
- Experience architecting and allocating requirements across multiple subsystems.
- Experience with Hazard Analysis), and Failure Mode and Effect Analysis (FMEA).
- Strong written, verbal, interpersonal and presentation skills.
- 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 and design validation activities.
- A minimum of 2 years of this experience in a SE role while operating under a quality system (e.g., ISO 13485)
- 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.
- 10% as needed to visit clinical sites to interact with users and observe procedures
Spectral AI, 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.