Description

Responsibilities

• Lead system integration activities throughout the product lifecycle, including architecture, development, verification, validation, design transfer, and sustaining support.
• Define integration strategies, interface requirements, sequencing plans, and risk mitigation activities.
• Support system architecture and integration requirements across hardware, software, firmware, mobile, and cloud platforms.
• Coordinate integration efforts across cross-functional engineering teams.
• Collaborate with Systems, Software, Hardware, Quality, Clinical, and Regulatory teams to ensure requirements are clear and integration-ready.
• Drive root-cause analysis and resolution of system integration issues.
• Support system-level verification and validation activities, ensuring test readiness and traceability.
• Communicate technical risks, trade-offs, project status, and system impacts to stakeholders and leadership.
• Lead technical reviews and ensure compliance with quality and regulatory processes.
• Work effectively with internal teams, suppliers, contractors, and external partners.

Required Qualifications

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related field with 5+ years of experience, or a Master's degree with 4+ years of experience.
• Experience leading integration of complex hardware and software systems.
• Strong understanding of systems engineering, architecture, interface management, and requirements allocation.
• Experience in regulated industries such as medical devices, aerospace, automotive, or similar.
• Hands-on collaboration with hardware, firmware, software, and systems teams.
• Knowledge of design controls, configuration management, change management, and defect tracking.
• Strong analytical, troubleshooting, and communication skills.
• Ability to work independently and succeed in a cross-functional environment.
• Experience supporting Class II or Class III medical device development and regulatory submissions.

Preferred Qualifications

• Experience with connected or software-enabled medical devices.
• Familiarity with IEC 62304, IEC 60601, ISO 14971, or related standards.
• Experience integrating mobile applications, Bluetooth, Wi-Fi, and cloud-based solutions.
• Experience with DOORS, Jama, JIRA, Polarion, or similar tools.
• Experience supporting verification, validation, design transfer, and automated system-level testing.
• Strong organizational skills, attention to detail, and systems-thinking mindset

Key Skills

Education

Bachelor's or Master's degrees