Senior System Engineer

Gentuity, LLC.; Sudbury (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

A medical device innovation company based in Sudbury, Massachusetts, is looking for a Systems Engineer to develop cutting-edge medical imaging hardware. The role involves writing technical specifications, leading cross-functional teams, and ensuring compliance with medical standards. Candidates should have a Bachelor's in electrical engineering and 8+ years of experience in the medical device industry. Strong skills in system architecture and requirements management are vital. This position offers a chance to contribute significantly to product development and innovation.

Qualifications

• 8+ years of experience in the medical device industry.
• Strong understanding of ISO 13485, IEC 60601-1 and IEC 60601-1-2.
• Experience with integrating, testing, and verifying complex medical systems.

Responsibilities

• Invent practical solutions for medical imaging hardware.
• Write and manage technical specifications and trace requirements.
• Support existing products with root cause failure analysis.
• Lead communication with remote teams as Systems Engineering lead.

Skills

System architecture

Requirements management

Specification writing

Problem-solving

Education

Bachelor's degree in electrical engineering (BSEE)

Tools

Schematic capture

PCBA design and testing

Job description

Description

• 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.
• 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).
• Must have experience integrating, testing, and verifying complex medical systems
• Experience with schematic capture, PCBA design and testing, motion control system is a plus
• Extensive experience working with consultants, outside partners, contract manufacturers and suppliers
• Ability to independently organize/align project tasks with department/corporate priorities