Senior System Engineer

Gentuity • Sudbury, MA

10d • Onsite

About The Position

Full-time, hands-on role inventing practical solutions to develop top-tier medical imaging hardware. Write and manage technical specifications (system, subsystem, and interface specs) and trace requirements through design, verification, and validation. Drive compliance testing strategy and execution for IEC 60601-1 electrical safety and IEC 60601-1-2 EMC requirements; coordinate lab testing, pre-compliance, and corrective actions. Plan and execute subsystem tests, systems integration and testing, and formal verification tests for medical devices. Support existing released products with root cause failure analysis, redesign for cost reduction, and iterations based on market feedback. Support manufacturing troubleshooting and complaints investigations as required. Lead communication with remote teams as Systems Engineering lead. Work effectively in cross-functional teams consisting of Research, Engineering, QA/RA, Marketing, Operations, Finance and other functions as a team player. Contribute to intellectual property creation and documentation. Coach and delegate tasks to junior associates.

Requirements

• Bachelor's degree in electrical engineering (BSEE) or related field required, with 8+ years of work experience in medical device industry.
• Strong understanding of ISO 13485, IEC 60601-1, 3.1 edition Safety and Essential performance and IEC60601-1-2 4th edition Electromagnetic disturbances.
• Strong skills in system architecture, requirements management, and specification writing.
• Must have experience integrating, testing, and verifying complex medical systems.
• Extensive experience working with consultants, outside partners, contract manufacturers and suppliers.
• Ability to independently organize/align project tasks with department/corporate priorities.

Nice To Haves

• Experience with photonic/optical system design and development is a plus.
• Familiarity with risk management (ISO 14971) and design control processes (21 CFR 820 / MDR equivalents).
• Experience with schematic capture, PCBA design and testing, motion control system is a plus.

Responsibilities

• Write and manage technical specifications (system, subsystem, and interface specs) and trace requirements through design, verification, and validation.
• Drive compliance testing strategy and execution for IEC 60601-1 electrical safety and IEC 60601-1-2 EMC requirements; coordinate lab testing, pre-compliance, and corrective actions.
• Plan and execute subsystem tests, systems integration and testing, and formal verification tests for medical devices.
• Support existing released products with root cause failure analysis, redesign for cost reduction, and iterations based on market feedback.
• Support manufacturing troubleshooting and complaints investigations as required.
• Lead communication with remote teams as Systems Engineering lead.
• Work effectively in cross-functional teams consisting of Research, Engineering, QA/RA, Marketing, Operations, Finance and other functions as a team player.
• Contribute to intellectual property creation and documentation.
• Coach and delegate tasks to junior associates.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior