Systems Engineer (Medical Devices) jobs in United States
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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

Medical Device IndustryISO 14971IEC 60601Requirements ManagementDFMEAData AnalysisTechnical Report WritingMATLABSimulinkCommunication SkillsCritical Thinking

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

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Randstad Digital is a trusted digital enablement partner that facilitates accelerated transformation for businesses by providing global talent, capacity, and solutions across specialized domains.

Funding

Current Stage
Late Stage

Leadership Team

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Graig Paglieri
CEO, Randstad Digital Americas
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Pascal de Hesselle
SVP, Executive Client Partner - Technology, Media & Telecom
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