Systems Integration Engineer-Medical Devices

Talent Groups

Pleasanton (CA)

On-site

USD 140,000 - 210,000

Full time

4 days ago
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Job summary

Talent Groups is seeking a Senior Systems Engineer in Pleasanton, CA, to lead system-level integration across hardware, embedded software, mobile, wireless, and cloud components throughout the product lifecycle. The role emphasizes regulated medical devices, design control, and cross-functional collaboration with engineering, quality, and regulatory teams.

The ideal candidate will have 8+ years of experience in systems engineering and strong evidence in system integration, architecture, and

Qualifications

  • 8+ years of Systems Engineering / System Integration experience.
  • Strong Hardware + Software integration experience.
  • System architecture, interface definition, and requirements management.
  • Medical device / regulated product experience.
  • Design control, configuration/change management, and defect tracking.
  • Root Cause Analysis and cross-functional issue resolution.

Responsibilities

  • Support Class II/III medical device regulatory submissions.

Skills

System integration
Hardware integration
Software integration
Root Cause Analysis
Cross-functional collaboration

Tools

DOORS
Jira

Job description

Location: Pleasanton, CA

Experience: 8+ Years

Job Summary:

Seeking a Senior Systems Engineer with strong experience in system-level integration of complex, regulated products, preferably medical devices. The role involves integrating hardware, embedded software, mobile, wireless, and cloud components across the product lifecycle.

Key Requirements:
  • 8+ years of Systems Engineering / System Integration experience
  • Strong Hardware + Software integration experience
  • System architecture, interface definition, and requirements management
  • Medical device / regulated product experience
  • Design control, configuration/change management, and defect tracking
  • Root Cause Analysis and cross-functional issue resolutionExperience supporting Class II/III medical device regulatory submissions
  • Preferred: IEC 62304, IEC 60601, ISO 14971, Bluetooth/Wi-Fi, Cloud, DOORS/Jira
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