Systems Engineer I: Requirements, Risk & Validation

SGS Consulting; Phoenix (AZ); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

SGS Consulting is seeking a Systems Engineering professional to lead requirements elicitation, risk analysis, and validation planning across cross-functional teams. You will analyze industry trends to strengthen validation strategies and collaborate with R&D, Marketing, Operations, Quality, and Regulatory groups to ensure regulatory alignment.

The role emphasizes traceability, risk management, and thorough verification throughout the system lifecycle, with opportunities to influence assay

Qualificações

• Educational background in engineering or biomedical fields with relevant experience.
• Demonstrated knowledge of systems engineering principles and verification/validation.
• Experience in regulated environments (FDA, ISO) for diagnostics products.

Responsabilidades

• Apply skills across requirements engineering, risk management, and V&V.
• Analyze industry trends and identify opportunities for robust validation.
• Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams.
• Engage with stakeholders to prioritize requirements and define validation criteria.
• Provide multiple solution paths for complex technical challenges and risk mitigation.
• Execute project deliverables for requirements, risk analysis, configuration, defects, and V&V using company tools.

Conhecimentos

Requirements elicitation

Risk analysis

V&V test strategy

Usability engineering

Leadership and communication

Organizational skills

Assay development

RE and traceability

RETINA tooling

LucidSpark/LucidChart

Software/electronics/IT/chemistry

Formação académica

Bachelor’s degree in engineering/Biomedical Sciences or related

4 years of experience (or Master’s with 2 years, or PhD)

Ferramentas

RETINA

LucidSpark

LucidChart

Descrição da oferta de emprego

SGS Consulting is seeking a Systems Engineering professional to lead requirements elicitation, risk analysis, and validation planning across cross-functional teams. You will analyze industry trends to strengthen validation strategies and collaborate with R&D, Marketing, Operations, Quality, and Regulatory groups to ensure regulatory alignment.

The role emphasizes traceability, risk management, and thorough verification throughout the system lifecycle, with opportunities to influence assay