Job Title : Senior Systems Engineer (Medical Devices only)
Location : St. Louis, MO onsite
No c2c*
Job Summary :
We are seeking a Senior Systems Engineer to collaborate with regulatory, quality, and R&D experts from the mechanical and electrical teams in defining system requirements, conducting risk assessments, and preparing documentation for verification activities.
The ideal candidate will have strong experience in requirements development, risk analysis, and test case writing for integrated medical systems, along with a deep understanding of relevant regulations and international standards.
At this phase of the project, the focus will be on finalizing labeling requirements, writing PCB requirements and associated test cases, and completing system-level DFMEA and harm-based risk analysis updates.
Key Responsibilities :
- Interpret and apply industry standards and regulations to ensure compliance with medical device requirements.
- Develop clear, testable system requirements from partially completed designs and subject matter expert inputs.
- Conduct comprehensive risk analysis at both the component and system levels, identifying design mitigations as necessary.
- Support test protocol development for system functions, surgical tools, and accessories.
- Troubleshoot and resolve integration and testing issues , proposing effective corrective actions to meet design goals.
- Refine subsystem requirements and plan life and reliability testing to ensure system longevity and functionality.
- Maintain traceability between design inputs / outputs, risk assessments, mitigations, and system architecture using Aras PLM .
Qualifications :
- Bachelor’s degree in Engineering (Systems, Biomedical, Electrical, Mechanical).
- 7+ years of experience in engineering, with a proven track record of launching complex electro-mechanical systems in high-regulatory environments.
- Strong expertise in risk analysis, requirements management , and verification planning .
- Proficiency with Aras PLM for maintaining traceability across project documentation.
- Excellent communication, organizational, and problem-solving skills.
- Self-motivated and capable of working independently with minimal supervision.
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