Software System Engineer

SEDAA•Pleasanton, CA

8h•Onsite

About The Position

We are seeking a Senior Software Systems Engineer to lead and execute software-level activities for complex, regulated medical devices. This senior-level individual contributor role focuses on translating customer and stakeholder needs into clear, actionable software and system requirements while ensuring compliance with regulatory standards and quality processes. The ideal candidate will serve as a technical subject matter expert, collaborating closely with Systems Engineering, Software Development, Quality, Clinical, Regulatory, and cross-functional teams to deliver high-quality software solutions for connected medical device platforms, cloud-based applications, and mobile solutions supporting patient care.

Requirements

Bachelor's degree in Systems Engineering, Biomedical Engineering, Software Engineering, Computer Science, or a related technical field 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, preferably medical devices (aerospace, automotive, or similar regulated industries also considered).
Demonstrated experience gathering business and product requirements from stakeholders and converting them into detailed software requirements, functional specifications, and interface definitions.
Strong understanding of requirements engineering, systems thinking, and software development processes.
Working knowledge of design control, configuration management, defect tracking, and change management processes.
Experience collaborating across multiple engineering disciplines in a cross-functional environment.
Excellent written and verbal communication skills with the ability to communicate complex technical concepts effectively.
Proven ability to work independently, prioritize multiple initiatives, and drive results in a matrixed organization.
Experience working in regulated product development environments (medical devices preferred).
Expertise in translating stakeholder needs into software requirements, functional specifications, and interface definitions.
Knowledge of design control, configuration management, defect tracking, and change management processes.
Strong cross-functional collaboration experience across engineering, quality, regulatory, and business teams.
Bachelor's degree with 5–6 years of relevant experience or Master's degree with 4+ years of relevant experience.

Nice To Haves

Experience in medical device development, particularly connected or software-enabled medical devices.
Working knowledge of cloud platforms such as AWS, Azure, or Google Cloud Platform (GCP)
Familiarity with mobile application ecosystems.
Experience with requirements, configuration, and defect management tools such as DOORS, JIRA, or similar platforms.
Familiarity with industry standards including: IEC 62304 (Software Lifecycle Processes), IEC 60601, ISO 14971 (Risk Management), and other relevant medical device software standards.

Responsibilities

Collaborate with clinical, regulatory, engineering, and commercial stakeholders to define product vision, business objectives, and high-level requirements for cloud and mobile healthcare solutions.
Translate user needs and intended use into detailed software requirements, functional specifications, interface definitions, and system-level documentation.
Ensure requirements are testable, traceable, allocatable, and compliant with applicable regulatory standards and quality system requirements.
Lead design reviews and technical reviews to ensure alignment with system architecture, risk controls, and design control processes.
Partner with Systems Engineering, Software Development, and Verification & Validation teams throughout the product lifecycle.
Support risk management activities, including hazard analysis, FMEA, and risk assessments, ensuring mitigations are reflected in requirements and verification plans.
Participate in cross-functional and leadership reviews, providing visibility into project status, technical risks, compliance, and system performance.
Communicate technical tradeoffs, integration challenges, and system impacts to stakeholders across the organization.
Serve as a subject matter expert for designated systems and contribute to solving complex technical and business challenges.
Coordinate with global engineering teams to ensure alignment and successful project execution.