System Engineer
3 weeks ago
Systems Engineer III | St. Louis, Missouri
Full-time | Contract | Onsite
NOTE: THIS IS NOT A SOFTWARE SYSTEMS ENGINEER ROLE
Kelly® Engineering is seeking a Systems Engineer III to support development of a new ophthalmic surgical system (including electromechanical console and compatible accessories) for our biomedical client in St. Louis, MO. This role is expected to be a 6-month contract position.
The candidate, in collaboration with regulatory, quality, and R&D SMEs on the mechanical and electrical teams will complete definition of requirements and FMEAs for the system and help prepare documentation for verification activities. Candidate is expected to be competent at requirements development, risk analysis, and test case writing for integrated medical systems and have a deep familiarity with the relevant regulations and international standards.
At this phase of the project, the largest areas needing support are finalizing labeling requirements, writing requirements for PCBs and tests for those requirements, and completing system-level DFMEA and harms-based risk analysis updates. Experience in at least one of those areas is required.
Key Responsibilities
- Read, understand, and interpret applicable industry standards and government regulations.
- Distill testable requirements from partial to complete designs and SME knowledge.
- Perform risk analysis at component and system levels and generate relevant design mitigations.
- Assist in test development for system, surgical functions, and accessories.
- Respond to integration & test issues with the best plans for rapid correction.
- Adjust drafted requirements for subsystems of medical devices. Determine strategy and needs for life testing, reliability testing necessary to hit design goals.
- Use Aras PLM to create traceability between design inputs, design outputs, design documentation, regulatory standards, risk items, mitigations, and architecture.
Minimum Qualifications/Education
- BS in Engineering (Systems, Biomedical, Electrical, Mechanical)
- 7+ years experience as an engineer.
- Proven track record of launching complex electro-mechanical systems with a high regulatory burden.
- Experience with risk analysis, requirement management, and verification planning. Excellent communication & organizational skills.
- High degree of self-motivation and direction.
Preferred requirements:
- Successfully launched a surgical medical device
- Deep familiarity with the relevant regulations and industry standards (FDA, MDR, CA, UKCA, ISO, IEC, ETSI, etc...).
- Experience using Aras PLM
- Familiarity with medical device labeling
All applicants applying for this job opening must be legally authorized to work in the United States and are required to have US residency at the time of application.
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