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Senior Systems Engineer, R&D - Edwards Lifesciences
Systems Engineer
Senior Systems Engineer leading the design and validation of implantable heart‑failure management devices, collaborating with quality and manufacturing teams, and applying embedded C++ development, MATLAB modeling, and LabVIEW testing within regulated FDA environments.
About the role
Key Responsibilities
- Design, develop, and integrate embedded hardware and firmware for implantable heart‑failure management systems.
- Create and execute MATLAB models and LabVIEW test rigs to validate device performance and safety.
- Collaborate closely with Quality, Manufacturing, and Clinical teams to ensure designs meet FDA regulatory and ISO standards.
- Lead root‑cause analysis and troubleshooting of hardware/software issues throughout the product lifecycle.
- Drive technical documentation, risk assessments, and design reviews in an Agile R&D environment.
Requirements
- Bachelor’s or higher in Electrical Engineering, Biomedical Engineering, or related field with 5+ years of embedded systems experience.
- Proficiency in C++ development for medical devices and strong hands‑on skills with MATLAB and LabVIEW.
- Demonstrated experience navigating FDA/ISO 13485 quality systems and conducting design verification/validation.
- Excellent problem‑solving abilities and ability to work cross‑functionally in fast‑paced R&D teams.
- Effective communication skills for technical documentation and stakeholder presentations.