Senior Medical Device Systems Engineer - Onsite Houston

Insight Global; Houston (TX); On-site; USD 96,000 - 124,000; Full time

Job summary

Insight Global is seeking a Senior Systems Engineer to support the development and commercialization of complex medical devices in Houston, onsite. You will coordinate across hardware, software, electrical, mechanical, quality and regulatory teams to ensure integrated system performance, safety and regulatory compliance.

The role involves translating user needs into system requirements, defining architecture, and maintaining traceability through design verification and validation, with hands-on

Qualifications

• Hands-on experience developing and managing system-level requirements.
• Translating user needs into system and subsystem requirements and defining interfaces.
• Experience with system architecture for hardware/software/electrical/mechanical products.
• Familiarity with ISO 14971 and risk-control measures and design-control environments.

Responsibilities

• Translate user needs into system requirements and maintain traceability through V&V.
• Define system architecture and interfaces across hardware, software, electrical and mechanical.
• Develop verification strategies and support testing activities and reports.
• Investigate defects, non-conformances, CAPAs and design changes; support change control.
• Collaborate across software, electrical, mechanical, quality, regulatory and testing teams to drive decisions.

Skills

Systems engineering

Requirements traceability

Risk management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Systems Engineering

Job description

Insight Global is seeking a Senior Systems Engineer to support the development and commercialization of complex medical devices in Houston, onsite. You will coordinate across hardware, software, electrical, mechanical, quality and regulatory teams to ensure integrated system performance, safety and regulatory compliance.

The role involves translating user needs into system requirements, defining architecture, and maintaining traceability through design verification and validation, with hands-on