Design Quality Engineer
Apply NowCompany: Spectral MD
Location: Texas City, TX 77590
Description:
Position Summary:
The Design Quality Engineer Role at Spectral MD is a cross-functional partner of engineering peers in Software, Optics, Electrical, Mechanical, Biomedical and Data Science teams. The Design Quality Engineer orchestrates the architecture and integration of an AI/ML driven Diagnostic Imaging Medical Device. The Design Quality Engineer plays a key role in performing Design Control related activities, Risk Management activities, and planning and tracing the System Verification and Validation. The role is primarily focused on new product research and development.
Essential Duties and Responsibilities:
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.
Plan for the Verification and Validation of the system requirements and user needs for the integrated system.
Plan and develop system level testing to ensure sub-systems maintain performance when integrated
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.
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.
Responsible for the following minimum deliverables:
o Requirements Analysis, User Needs, System Requirements, Subsystem Requirements
o Risk Analysis, Preliminary Hazard Analysis, Device Hazard Analysis, FMEAs (e.g. software, use, design)
o Traceability Matrix
o 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.
The Design Quality Engineer Role at Spectral MD is a cross-functional partner of engineering peers in Software, Optics, Electrical, Mechanical, Biomedical and Data Science teams. The Design Quality Engineer orchestrates the architecture and integration of an AI/ML driven Diagnostic Imaging Medical Device. The Design Quality Engineer plays a key role in performing Design Control related activities, Risk Management activities, and planning and tracing the System Verification and Validation. The role is primarily focused on new product research and development.
Essential Duties and Responsibilities:
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.
Plan for the Verification and Validation of the system requirements and user needs for the integrated system.
Plan and develop system level testing to ensure sub-systems maintain performance when integrated
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.
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.
Responsible for the following minimum deliverables:
o Requirements Analysis, User Needs, System Requirements, Subsystem Requirements
o Risk Analysis, Preliminary Hazard Analysis, Device Hazard Analysis, FMEAs (e.g. software, use, design)
o Traceability Matrix
o 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.