Senior Software Systems Engineer – Medical Devices

We are seeking a Senior Software Systems Engineer to lead system-level development for connected digital applications within infusion pump platforms. This is a hands-on technical leadership role in a highly regulated medical device environment, focused on architecture, requirements, risk management, and regulatory compliance.

Key Responsibilities

• Lead system and software architecture for connected medical device platforms
• Capture user needs and translate them into system and software requirements
• Decompose system requirements into software subsystems
• Lead risk management activities (hazards, mitigations, traceability)
• Partner with V&V teams on test strategy and compliance
• Participate in and lead software design reviews
• Collaborate with cross-functional teams in an Agile environment

Required Qualifications

• Bachelor’s degree in Engineering or related field
• 10+ years of experience in software systems engineering
• Strong experience with requirements management, risk management, and system-of-systems architecture
• Experience in a regulated industry (medical devices strongly preferred)
• Familiarity with IEC 62304, ISO 14971, FDA design controls

Preferred

• Experience with SaMD / MDDS
• Connected or interoperable medical devices
• Exposure to clinical environments

Open on C2C / W2

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