Job description

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 –Test bed development –Troubleshooting skills –Developing comprehensive testing plans. –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: 8 yrs –Experience in a FDA or FAA regulated environment is a strong plus; Medical device industry is ideal Pay Rate Range: $50-60/hr depending on experience

Requirements

Must-haves

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.
TMV, Test Method Development, DoE, data analysis (python coding capability)
Digital outputs of a sensor and analyze the data
Test bed development
Troubleshooting skills
Developing comprehensive testing plans.
Executing hands-on testing protocols.
Authoring detailed technical reports.
Managing the defect lifecycle (collection, documentation, and summarization for our development partner).
Years of Experience: 8 yrs
Experience in a FDA or FAA regulated environment is a strong plus; Medical device industry is ideal
Pay Rate Range: $50-60/hr depending on experience

Nice-to-haves

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

Application prep

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Keywords to mirror

jirapython

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