Tekhawks

SYSTEMS ENGINEER – INTEGRATION

Location: Pleasanton, CA

Duration: 1 year, possible extensions

Overview

Seeking a senior-level Systems Engineer to lead system-level integration for complex, regulated medical devices. The engineer will coordinate the integration of hardware, embedded software, mechanical components, mobile applications, wireless technologies, and cloud-connected services across new product development and sustaining programs.

Responsibilities

• Lead system integration planning and execution across the full product lifecycle.
• Define the integration strategy, sequencing, interface definitions, and mitigation of integration risks.
• Support system architecture, integration requirements, and interface control across hardware and software domains.
• Coordinate end-to-end integration across embedded firmware, mechanical, mobile, wireless, and cloud components.
• Ensure requirements are clear, allocatable, and integrable across engineering disciplines.
• Identify integration issues early and drive them through root-cause analysis and resolution.
• Ensure integrated systems are traceable, test-ready, and prepared for formal verification and validation.
• Communicate technical risks, tradeoffs, system impacts, and project status to cross-functional teams and leadership.
• Support design transfer, sustaining activities, and applicable quality-system requirements.

Target Background

• Bachelor’s degree with approximately 5–6 years of relevant experience, or a master’s degree with at least 4 years of relevant experience.
• Demonstrated experience leading system integration for complex products involving both hardware and software.
• Strong understanding of system architecture, interface control, integration sequencing, and multi-component system behavior.
• Hands-on experience working across Systems, Software, Hardware, and Test Engineering.
• Experience in regulated product development; medical device experience is strongly preferred, although aerospace, automotive, or similar industries may be considered.
• Working knowledge of design controls, configuration management, defect tracking, and change-management processes.
• Experience supporting Class II/III medical device submissions is highly desirable.
• Experience with DOORS, JIRA, or similar requirements and defect-management tools.
• Familiarity with IEC 62304, IEC 60601, ISO 14971, or comparable standards is preferred.

Experience integrating mobile applications, Bluetooth, Wi-Fi, cloud services, embedded firmware, and automated electromechanical system tests is preferred