Sr. Systems Engineer

JOB SUMMARYWe are seeking a highly experienced Senior Systems Engineer to join a hands-on engineering team developing innovative medical devices and imaging technologies. This role will lead systems engineering activities across requirements management, system architecture, integration, verification, validation, compliance testing, and support of released products.The ideal candidate brings strong medical device industry experience, excellent systems engineering fundamentals, and the ability to collaborate effectively across engineering, research, quality/regulatory, operations, and other cross-functional teams.KEY RESPONSIBILITIESDevelop and manage technical specifications, including system, subsystem, and interface specifications.Trace requirements through design, verification, and validation activities.Drive compliance testing strategy and execution for IEC 60601-1 electrical safety and IEC 60601-1-2 EMC requirements.Coordinate laboratory testing, pre-compliance activities, and corrective actions.Plan and execute subsystem testing, systems integration and testing, and formal verification testing for medical devices.Support released products through root cause failure analysis, redesign for cost reduction, and product improvements based on market feedback.Support manufacturing troubleshooting and complaint investigations as needed.Lead systems engineering communications with remote teams and serve as a technical systems engineering lead.Collaborate with Research, Engineering, QA/RA, Marketing, Operations, Finance, and other functions.Work with consultants, outside partners, contract manufacturers, and suppliers.Contribute to intellectual property development and technical documentation.Coach and delegate tasks to junior engineering team members.Independently organize and align project activities with departmental and corporate priorities.REQUIRED QUALIFICATIONSBachelor's degree in Electrical Engineering or a related engineering field.8+ years of professional experience in the medical device industry.Strong understanding of ISO 13485.Strong understanding of IEC 60601-1, including electrical safety and essential performance requirements.Strong understanding of IEC 60601-1-2 electromagnetic compatibility requirements.Strong experience with system architecture, requirements management, and technical specification development.Hands-on experience integrating, testing, and verifying complex medical systems.Familiarity with risk management, including ISO 14971, and medical device design control processes.Ability to independently manage priorities and coordinate technical activities.Strong communication, problem-solving, and cross-functional collaboration skills.PREFERRED QUALIFICATIONSExperience with photonic or optical system design and development.Experience with schematic capture, PCBA design, and testing.Experience with motion control systems.Experience working with consultants, contract manufacturers, suppliers, and external engineering partners.Experience supporting products through development, verification, validation, manufacturing, and post-release activities.Work EnvironmentThis is a full-time, hands-on engineering position based in Sudbury, Massachusetts. The role requires close collaboration with cross-functional engineering and business teams and may involve interaction with remote teams, external partners, and manufacturing organizations.