Sr R&D Engineer, Electromechanical Catheter Systems (Onsite)

Overview When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives. Responsibilities The Sr. R&D Engineer, Electromechanical Catheter Systems, is responsible for the design, development, testing, and manufacturing implementation of cardiovascular catheter-based technologies incorporating mechanical, electrical, electronic, and programmable subsystems. The role combines hands-on engineering with system-level problem solving to support safe, robust, and controlled delivery of therapeutic energy and successful transfer of devices and associated manufacturing processes into production. Applies comprehensive medical device engineering knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. May contribute to the development of policies and procedures. Works on complex projects of medium scope. Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives. Design, integrate, prototype, and evaluate electromechanical catheter systems, including catheters, electrical interfaces, sensors, connectors, control electronics, generators, and related accessory devices. Troubleshoot electrical and electromechanical systems, identify root causes of functional or performance issues, and recommend design, component, or control-system improvements. Plan and execute electrical and system-level tests, including voltage, current, power, impedance, continuity, insulation, signal integrity, and functional performance testing, as applicable to the device architecture. Evaluate and recommend energy-delivery methods and operating parameters, including power, energy, pulse duration, waveform, frequency, and treatment dosage, using bench data, system constraints, and risk-based design requirements. Develop, integrate, and verify programmable control systems that regulate energy output and treatment dosage; assess parameter limits, feedback mechanisms, alarms, interlocks, fault detection, and other safety-related controls. Create and execute engineering test methods, verification protocols, and design studies; analyze results, document findings, and confirm performance against design inputs and specifications. Lead or contribute to design reviews, design documentation, risk assessments, and technical investigations, ensuring solutions are evaluated, documented, and appropriately tested. Partner with manufacturing engineering and external suppliers to develop, install, commission, and qualify equipment and processes used to assemble, calibrate, test, and manufacture electromechanical medical device systems. Support equipment and process qualification activities (e.g., IQ/OQ/PQ, as applicable), including test fixtures, automated test equipment, calibration procedures, acceptance criteria, process capability, and troubleshooting during scale-up. Work independently on assigned design activities, collaborate across disciplines, and act as technical project lead as needed; develop and monitor schedules to deliver assigned milestones on time. Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related field required. A minimum of 5+ years related work experience. Experience working in the design and development of medical devices. Demonstrated hands-on experience testing and troubleshooting electrical or electromechanical systems using appropriate laboratory instrumentation (e.g., oscilloscopes, multimeters, power analyzers, and data-acquisition systems). Experience with programmable systems that control or monitor energy delivery, output parameters, or therapeutic dosage, including hardware/software integration and functional verification. Experience translating system requirements into test protocols, analyzing engineering data, and documenting design verification or technical investigations. Experience supporting installation, validation, or qualification of manufacturing equipment and processes for electromechanical products

The Sr. R&D Engineer, Electromechanical Catheter Systems, is responsible for the design, development, testing, and manufacturing implementation of cardiovascular catheter-based technologies incorporating mechanical, electrical, electronic, and programmable subsystems. The role combines hands-on engineering with system-level problem solving to support safe, robust, and controlled delivery of therapeutic energy and successful transfer of devices and associated manufacturing processes into production. Applies comprehensive medical device engineering knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. May contribute to the development of policies and procedures. Works on complex projects of medium scope. Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives. Design, integrate, prototype, and evaluate electromechanical catheter systems, including catheters, electrical interfaces, sensors, connectors, control electronics, generators, and related accessory devices. Troubleshoot electrical and electromechanical systems, identify root causes of functional or performance issues, and recommend design, component, or control-system improvements. Plan and execute electrical and system-level tests, including voltage, current, power, impedance, continuity, insulation, signal integrity, and functional performance testing, as applicable to the device architecture. Evaluate and recommend energy-delivery methods and operating parameters, including power, energy, pulse duration, waveform, frequency, and treatment dosage, using bench data, system constraints, and risk-based design requirements. Develop, integrate, and verify programmable control systems that regulate energy output and treatment dosage; assess parameter limits, feedback mechanisms, alarms, interlocks, fault detection, and other safety-related controls. Create and execute engineering test methods, verification protocols, and design studies; analyze results, document findings, and confirm performance against design inputs and specifications. Lead or contribute to design reviews, design documentation, risk assessments, and technical investigations, ensuring solutions are evaluated, documented, and appropriately tested. Partner with manufacturing engineering and external suppliers to develop, install, commission, and qualify equipment and processes used to assemble, calibrate, test, and manufacture electromechanical medical device systems. Support equipment and process qualification activities (e.g., IQ/OQ/PQ, as applicable), including test fixtures, automated test equipment, calibration procedures, acceptance criteria, process capability, and troubleshooting during scale-up. Work independently on assigned design activities, collaborate across disciplines, and act as technical project lead as needed; develop and monitor schedules to deliver assigned milestones on time.

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related field required. A minimum of 5+ years related work experience. Experience working in the design and development of medical devices. Demonstrated hands-on experience testing and troubleshooting electrical or electromechanical systems using appropriate laboratory instrumentation (e.g., oscilloscopes, multimeters, power analyzers, and data-acquisition systems). Experience with programmable systems that control or monitor energy delivery, output parameters, or therapeutic dosage, including hardware/software integration and functional verification. Experience translating system requirements into test protocols, analyzing engineering data, and documenting design verification or technical investigations. Experience supporting installation, validation, or qualification of manufacturing equipment and processes for electromechanical products