Job Duration: 12 months Contract (Possibility of extension)
Description: This is an onsite position for a motivated, hands‑on Systems Engineer or Senior Systems Engineer who has experience with electro‑mechanical devices.
Summary:
- Deliver V-Model systems engineering outputs and participate in design reviews.
- Conduct development and testing to evaluate performance against design specifications and system interactions.
- Ensure assays operate efficiently and effectively using the latest technologies and systems.
- Execute project deliverables—including requirements, risk, configuration management, defect management, and verification and validation—within the company-specific tool.
Preferred qualifications:
- Has expertise in translating industry standards, government regulations, and high‑level stakeholder mandates into clear, testable engineering requirements.
- Has experience and ability to read, interpret, and trace legal, safety, and industry regulations (e.g., ISO, IEC, FDA, EU standards) without losing intent.
- Has experience in extracting functional, performance, interface, and constraint requirements from dense regulatory text and ambiguous stakeholder inputs.
- Has experience breaking down high‑level "shall" statements or compliance mandates into lower‑level requirements for hardware, software, and system.
- Has experience establishing bi‑directional traceability (e.g., using tools like RETINA, DOORS, or Jira) linking source regulations → system requirements → design specifications → verification tests.
Key responsibilities:
- TMV, Test Method Development, DoE, data analysis (python coding capability).
- Digital outputs of a sensor and analyze the data.
- Executing hands‑on testing protocols.
- Authoring detailed technical reports.
- Managing the defect lifecycle (collection, documentation, and summarization for our development partner).
Education & experience:
- Degree: Bachelor's degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred).
- Years of Experience: 4+ years for Systems Engineer level; 8+ years for Senior Systems Engineer level.
- Experience in an FDA or FAA regulated environment is a strong plus; Medical device industry is ideal.