Senior Medical Systems Engineer - Imaging & Compliance Lead

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

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.