job summary:
Systems Engineer to support new medical device development projects. In this role, you will act as a technical bridge, supporting the Project Manager to ensure alignment across Software, Electrical, and Mechanical engineering leads. You will be responsible for the "technical glue" of the project-translating customer needs into rigorous requirements and ensuring the final product is safe, compliant, and traceable.
location: St. Petersburg, Florida
job type: Contract
salary: $42 - 52 per hour
work hours: 9am to 5pm
education: Bachelors
responsibilities:
- Technical Alignment & Support: Assist the Project Manager in establishing the development approach; help "level-set" and coordinate between the Software, Verification, Electrical, and Mechanical project leads.
- Requirements Management: Own the process of writing, managing, and translating complex medical device requirements.
- Traceability Mapping: Build and maintain the traceability matrices required to prove the device meets all design and safety specifications.
- Risk & Compliance: Support risk management activities, including participating in DFMEA sessions and ensuring adherence to safety standards.
- Documentation: Author technical reports, data analysis summaries, and design history file (DHF) documentation.
- Customer Interaction: Serve as a technical point of contact for customer inquiries, clearly communicating complex engineering information.
Critical Required Qualifications- Experience: 5+ years of professional experience specifically within the Medical Device Industry .
- Regulatory Standards: Proven experience working with ISO 14971 (Risk Management) and IEC 60601 (Safety/Performance). Candidates without experience in these standards will not be considered.
- Education: BS in Mechanical (ME), Electrical (EE), Software (SW), or Biomedical Engineering is required .
- Writing & Analysis: Strong experience in technical report writing and data analysis.
- Location: Must be able to work 100% On-site in St. Petersburg, FL.
Technical Skills & Tools- Requirements: Experience managing/writing requirements is a must. (Experience with Modern Requirements or Azure DevOps/ADO is a significant plus).
- Risk Tools: Experience with DFMEA is highly preferred.
- Modeling: Experience with MATLAB / Simulink is a plus.
- Soft Skills: Exceptional communication and critical thinking skills are required for customer-facing duties and internal cross-functional coordination.
qualifications:
- Experience: 5+ years of professional experience specifically within the Medical Device Industry.
- Education: BS in Mechanical (ME), Electrical (EE), Software (SW), or Biomedical Engineering is required.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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