Systems Engineer Medical Device

Based in Pleasanton, CA, the engineer is accountable for ensuring that all system elements are effectively integrated, interfaces are clearly defined and verified, and overall system performance meets intended use, quality standards, and regulatory requirements.

The role requires strong technical depth, systems thinking, and the ability to operate with minimal supervision while independently leading integration efforts. The engineer collaborates closely with cross-functional teams - including Systems, Software, Hardware, Quality, Clinical, and Regulatory - and coordinates with global engineering personnel to ensure alignment, resolve interdependencies, and drive successful project completion.

RESPONSIBILITIES

• Lead system integration planning and execution across the full product lifecycle,

from early architecture through verification, design transfer, and sustaining

activities

• Define and manage the system integration strategy, including integration

sequencing, interface definition, and mitigation of integration risks

• Support and maintain system architecture, interface definitions, and integration

requirements across hardware and software domains

• Coordinate end-to-end integration activities across embedded firmware,

mechanical components, mobile applications, and cloud-connected services

Partner with Systems, Software, and Hardware Engineering to ensure

requirements are clear, allocatable, integrable, and that integration issues are

identified early and resolved through root-cause analysis

• Support system-level verification and validation by ensuring integrated systems

are test-ready, traceable, and issues are resolved prior to formal testing

• Communicate integration risks, technical tradeoffs, and system impacts, lead

technical reviews, provide mentorship, and ensure compliance with applicable

quality system requirements

• Communicate effectively with cross-functional teams and senior management.

Keeps leadership informed of progress and issues.

• Cooperative communications and collaboration with all levels of employees,

customers, contractors, and vendors.

Required

• Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical

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 leading system integration for complex products

involving both hardware and software

• Strong understanding of system architecture, interface control, and multi-

component system behavior

• Experience working in regulated product development environments (medical

devices strongly preferred; aerospace, automotive, or similar also acceptable)

• Hands-on experience collaborating across hardware, software, and systems

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

• Experience supporting regulatory submissions for Class II/III medical devices

Preferred:

• Medical device experience, particularly with connected or software-enabled

medical devices.

• Familiarity with relevant standards such as IEC 62304 (Software Lifecycle),

IEC 60601, ISO 14971, or similar

• Experience integrating systems involving mobile applications, wireless

technologies (e.g., Bluetooth, Wi‑Fi), and cloud-based services

• Experience working with requirements, configuration, and defect

management tools (e.g., DOORS, JIRA, etc.)

• Experience supporting system integration through verification, validation,

and design transfer

• Strong systems-thinking mindset with the ability to balance technical depth

and big-picture impacts

• Strong organizational skills, ability to prioritize work, and consistent attention

to detail

• Experience developing or supporting automated system-level tests involving

integrated mechanical, electrical, and software components