Systems Engineer II, R&D
Core
Develop hardware components and new product designs for the Cordella platform to address unmet clinical needs in structural heart disease.
Role type
Systems Engineer II, R&D (Hardware)
Builds
Hardware components for the Cordella platform (Implantable Heart Failure Management system)
Domain
Medical devices / Structural heart disease
Deliverable
production ML models | product features
Required skills
Design control documentation, risk management, design change impact assessment, user research, system-level problem-solving, test execution coordination, technical reporting
Preferred skills
V&V testing, Design Controls/DHF ownership, FDA/ISO 13485 standards, data analysis and scripting (Excel/Minitab)
Technologies
Excel, Minitab
Responsibilities
Support development and execution of engineering project plans; Create work instructions, test methods, models, and prototypes; Develop and update design control documentation; Perform design change impact assessments; Conduct user research and usability evaluations; Maintain Design History File (DHF); Coordinate test execution with technicians; Evaluate technical inputs for design recommendations
Seniority
Mid-level IC (2+ years experience or Master's with thesis)