Engineer - Degreed IV

Senior Software Systems Engineer / Requirements Engineer (Medical Device)

Location: Pleasanton, CA (Onsite)
Pay Rate: $60-$67/hr
Duration: 5-Month Contract (Initial Assignment)

Position Overview

We are seeking a Senior Software Systems Engineer to support the development of innovative software-enabled medical device solutions focused on heart failure management. This individual contributor role will lead software requirements engineering activities, serving as a technical expert responsible for translating customer, clinical, regulatory, and business needs into detailed software and system requirements.

The ideal candidate will have experience working within regulated product development environments and possess strong expertise in requirements management, systems engineering, design controls, and cross-functional collaboration. This role requires close partnership with Systems Engineering, Software Development, Quality, Clinical, Regulatory, and Verification & Validation teams to ensure successful product delivery while maintaining compliance with applicable industry standards and regulations.

Key Responsibilities

• Collaborate with Clinical, Regulatory, Engineering, Quality, and Commercial stakeholders to define product vision, business objectives, and high-level requirements for cloud and mobile healthcare solutions.
• Translate customer needs, intended use, and business objectives into detailed software requirements, functional specifications, interface definitions, and system requirements.
• Ensure requirements are testable, traceable, verifiable, and compliant with applicable regulatory standards and quality processes.
• Lead requirements reviews, design reviews, and technical discussions to ensure alignment with system architecture and risk management objectives.
• Partner with Systems Engineering, Software Development, and Verification & Validation teams to ensure proper decomposition, allocation, integration, and testing of requirements.
• Participate in risk management activities including hazard analysis, FMEA, and risk assessments in accordance with ISO 14971.
• Ensure risk controls and mitigations are appropriately captured in requirements, designs, and verification activities.
• Support design control, change management, defect tracking, and configuration management processes.
• Communicate technical tradeoffs, integration risks, system impacts, and project status to cross-functional teams and leadership.
• Serve as a subject matter expert for assigned systems and software functionality.
• Coordinate with global engineering teams to drive alignment and successful project execution.

Required Qualifications

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Software Engineering, Computer Science, or related technical discipline with 5-6 years of relevant experience; OR
• Master's degree in a related technical field with 4+ years of relevant experience.
• Experience working in regulated product development environments (medical device preferred; aerospace, automotive, or other highly regulated industries acceptable).
• Demonstrated experience gathering business requirements and converting them into detailed software requirements, functional specifications, and interface definitions.
• Experience collaborating across multiple engineering disciplines including Systems, Software, Quality, and Verification teams.
• Working knowledge of:
  • Design Controls
  • Configuration Management
  • Defect Tracking
  • Change Management Processes
• Strong written and verbal communication skills.
• Ability to work independently and effectively within a matrixed organization.

Preferred Qualifications

• Medical device industry experience, especially connected or software-enabled devices.
• Familiarity with FDA-regulated product development environments.
• Knowledge of:
  • IEC 62304 (Software Lifecycle Processes)
  • ISO 14971 (Risk Management)
  • IEC 60601
• Experience with requirements and defect management tools such as DOORS, Jama, Jira, Azure DevOps, Polarion, or similar.
• Working knowledge of cloud platforms:
  • AWS
  • Azure
  • Google Cloud Platform (GCP)
• Experience supporting cloud-based and mobile application ecosystems.