Senior Systems Engineer

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:

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  Deliver V-Model systems engineering outputs and participate in design reviews.

  
  
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  Conduct development and testing to evaluate performance against design specifications and system interactions.

  
  
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  Ensure assays operate efficiently and effectively using the latest technologies and systems.

  
  
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  Execute project deliverables-including requirements, risk, configuration management, defect management, and verification and validation-within the company-specific tool.

  
  

PREFERRED QUALIFICATIONS:

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  Has expertise in translating industry standards, government regulations, and high-level stakeholder mandates into clear, testable engineering requirements.

  
  
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  Has experience and ability to read, interpret, and trace legal, safety, and industry regulations (e.g., ISO, IEC, FDA, EU standards) without losing intent.

  
  
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  Has experience in extracting functional, performance, interface, and constraint requirements from dense regulatory text and ambiguous stakeholder inputs.

  
  
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  Has experience breaking down high-level "shall" statements or compliance mandates into lower-level requirements for hardware, software, and system.

  
  
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  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:

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  TMV, Test Method Development, DoE, data analysis (python coding capability).

  
  
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  Digital outputs of a sensor and analyze the data.

  
  
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  Test bed development.

  
  
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  Troubleshooting skills.

  
  
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  Developing comprehensive testing plans.

  
  
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  Executing hands-on testing protocols.

  
  
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  Authoring detailed technical reports.

  
  
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  Managing the defect lifecycle (collection, documentation, and summarization for our development partner).

  
  

EDUCATION & EXPERIENCE:

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  Degree: Bachelor's degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred).

  
  
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  Years of Experience: 4+ years for Systems Engineer level; 8+ years for Senior Systems Engineer level.

  
  
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  Experience in an FDA or FAA regulated environment is a strong plus; Medical device industry is ideal.