Randstad Digital Americas ยท 1 day ago
Systems Engineer (Medical Devices)
Randstad Digital Americas is seeking a Systems Engineer to support new medical device development projects. In this role, you will act as a technical bridge, ensuring alignment across various engineering leads and translating customer needs into rigorous requirements.
Information Technology & Services
Responsibilities
Assist the Project Manager in establishing the development approach; help "level-set" and coordinate between the Software, Verification, Electrical, and Mechanical project leads
Own the process of writing, managing, and translating complex medical device requirements
Build and maintain the traceability matrices required to prove the device meets all design and safety specifications
Support risk management activities, including participating in DFMEA sessions and ensuring adherence to safety standards
Author technical reports, data analysis summaries, and design history file (DHF) documentation
Serve as a technical point of contact for customer inquiries, clearly communicating complex engineering information
Qualification
Required
5+ years of professional experience specifically within the Medical Device Industry
Proven experience working with ISO 14971 (Risk Management) and IEC 60601 (Safety/Performance). Candidates without experience in these standards will not be considered
BS in Mechanical (ME), Electrical (EE), Software (SW), or Biomedical Engineering is required
Strong experience in technical report writing and data analysis
Must be able to work 100% On-site in St. Petersburg, FL
Experience managing/writing requirements is a must
Exceptional communication and critical thinking skills are required for customer-facing duties and internal cross-functional coordination
Preferred
Experience with Modern Requirements or Azure DevOps/ADO is a significant plus
Experience with DFMEA is highly preferred
Experience with MATLAB / Simulink is a plus
Benefits
Medical
Prescription
Dental
Vision
AD&D
Life insurance offerings
Short-term disability
401K plan
Company
Randstad Digital Americas
Randstad Digital is a trusted digital enablement partner that facilitates accelerated transformation for businesses by providing global talent, capacity, and solutions across specialized domains.