Research & Development Systems Engineer

United States·ColumbiaFull Timemid

Systems EngineerInfrastructure & Cloud

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General Summary of the Position The Research & Development Systems Engineer will work upstream of formal design controls, focusing on architecture definition, system integration,

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Systems EngineerInfrastructure & Cloud

The Research & Development Systems Engineer will work upstream of formal design controls, focusing on architecture definition, system integration, early risk identification and mitigation, and the translation of voice-of-customer (VOC) into innovative medical device systems. This role emphasizes system-level thinking, bringing together hardware, software, biosignal acquisition, and user interaction into innovative medical products

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

Must be able to use typical office equipment including, but not limited to, telephone, fax machine, copier, and computer.
May be required to lift items up to 25 pounds in weight
Ability to use typical equipment found in laboratory environments
Must have manual dexterity as part of the component design and evaluation process

Ability to integrate qualitative VOC and user feedback into technical system decisions
Strong communication skills with the ability to document and articulate assumptions, risks, tradeoffs, and system behavior
Ability to manage and collaborate with internal and external design & development partners and 3rd party vendors
Working knowledge in electrical and mechanical engineering

Bachelor’s degree in Engineering (Electrical, Biomedical, Systems, Computer Engineering, or related field)
5-7 years of experience in medical device R&D or product design
Demonstrated experience developing medical devices or regulated products at a systems level
Hands-on or architectural experience with biosignal acquisition systems (EEG, EMG, ECG, or similar)
Experience identifying, documenting, and managing system-level risks
Exposure to both hardware and software development is preferred
Experience supporting or transitioning systems into formal design controls (ISO 13485 / FDA design control requirements) preferred
Familiarity with usability engineering, clinical workflows, or human-factors considerations preferred