Product Systems Engineer

Title: Systems Engineer

Location: Pleasanton, CA

Work Arrangement: Onsite

Pay Rate: 90k-100k

Position Summary

Position is for a senior-level individual contributor responsible for leading and executing software-level activities for complex, regulated medical devices. This role focuses on capturing and translating customer and stakeholder requirements into clear, actionable requirements and specifications, ensuring alignment across development and testing teams. Acting as a subject matter expert, this role provides technical leadership and guidance to deliver high-quality software solutions that meet regulatory standards and customer needs.

Based in Pleasanton, CA, the role requires strong technical depth, systems thinking, and the ability to operate with minimal supervision. The engineer collaborates closely with cross-functional teams—including Systems, Software, Quality, Clinical, and Regulatory—and coordinates with global engineering personnel to ensure alignment, resolve interdependencies, and drive successful project completion.

Responsibilities

• Collaborate with cross-functional stakeholders (clinical, regulatory, engineering, and commercial teams) to define product vision, business objectives, and high-level requirements for cloud and mobile solutions supporting heart failure management.
• Own end-to-end requirements definition, translating user needs and intended use into detailed software/system requirements, functional specifications, and interface definitions that are testable, traceable, and compliant with regulatory standards (e.g., FDA, IEC 62304).
• Lead and facilitate design and technical reviews, ensuring alignment with system architecture, requirements integrity, risk controls, and compliance with quality system processes and design controls.
• Partner closely with Systems Engineering, Software Development, and Verification/Validation teams to ensure requirements are clear, decomposed, allocatable, testable, and integrable across subsystems.
• Contribute to risk management activities, including hazard analysis, FMEA, and risk assessments (ISO 14971); ensure risk mitigations are properly captured in requirements, design, and verification plans.
• Actively participate in cross-functional and leadership reviews, providing clear visibility into product progress, system performance, risks, and compliance status.
• Foster strong collaboration and communication across all levels of the organization, including internal teams, customers, vendors, and external partners.
• Develop and apply an expert understanding of designated systems as well as serve as a subject matter expert to solve problems and deliver upon business objectives.
• Communicate integration risks, technical tradeoffs, and system impacts and ensure compliance with applicable quality system requirements.

Education and Experience

Required

• 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 a minimum of 4 years of relevant experience.
• Demonstrated experience collaborating with internal stakeholders to understand business objectives and high-level product requirements, then convert them into detailed software requirements, functional specifications, and interface definitions.
• Experience working in regulated product development environments (medical devices strongly preferred, aerospace, automotive, or similar also acceptable).
• Hands-on experience collaborating across engineering disciplines.
• Working knowledge of design control, configuration management, defect tracking, and change management processes.
• Excellent written and verbal communication skills, with the ability to clearly communicate complex technical concepts to cross-functional stakeholders.
• Proven ability to work independently, prioritize effectively, and drive results in a matrixed organization.

Preferred

• Medical device experience, particularly with connected or software-enabled medical devices.
• Working knowledge of cloud-based platforms (AWS, Azure, GCP) and mobile application ecosystems.
• Experience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.).
• Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), IEC 60601, ISO 14971, or similar.

Hard Requirements (3–5)

• Experience working in regulated product development environments (medical devices strongly preferred, aerospace, automotive, or similar also acceptable).
• Working knowledge of design control, configuration management, defect tracking, and change management processes.
• Demonstrated experience collaborating with internal stakeholders to understand business objectives and high-level product requirements, then convert them into detailed software requirements, functional specifications, and interface definitions.
• Hands-on experience collaborating across engineering disciplines.
• Bachelor's degree with 5-6 years of relevant experience or Master's degree with 4 years of relevant experience.

Preferred Requirements That Would Stand Out on a Resume

• Working knowledge of cloud-based platforms (AWS, Azure, GCP) and mobile application ecosystems.
• Experience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.).
• Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), IEC 60601, ISO 14971, or similar.
• Medical device experience, particularly with connected or software-enabled medical devices.

Daily Tasks / Duties

• Define and manage software/system requirements and functional specifications.
• Collaborate with Systems Engineering, Software Development, Verification & Validation, Quality, Clinical, Regulatory, and Commercial teams.
• Lead design and technical reviews.
• Support risk management activities including hazard analysis, FMEA, and risk assessments.
• Ensure compliance with design controls, quality system processes, and regulatory requirements.
• Communicate technical tradeoffs, integration risks, and system impacts to stakeholders.
• Participate in leadership and cross-functional reviews to provide project status, risks, and compliance updates.