Gentuity, LLC · 1 day ago
Senior System Engineer
Sudbury,MA,US
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expGentuity, LLC is a company focused on developing advanced medical imaging hardware. They are seeking a Senior System Engineer to drive compliance testing, manage technical specifications, and support product troubleshooting while collaborating with cross-functional teams.
Health CareManufacturingMedical Device
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
Qualification
Required
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
Preferred
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
Company
Gentuity, LLC
Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today’s best-in-class technologies.
51-200 employees
H1B Sponsorship
Gentuity, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
David W. Kolstad
Chief Executive Officer
Christopher Petersen
Co-founder and Senior Vice President
Recent News
2025-09-09
Medical Product Outsourcing
2025-08-13
Company data provided by crunchbase