
Senior Design Engineer
- Valencia
- Permanente
- Tiempo completo
- Design, development, and testing of hardware components and systems, ensuring alignment with product requirements and regulatory standards.
- Work closely with cross-functional teams (systems, biomedical, mechanical, firmware) to integrate, test & debug hardware platforms.
- Rapid prototyping for proof-of-concept devices and data acquisition platforms. Optimize hardware design (bio-medical/ mechanical and electrical), schematics, and PCB layouts, ensuring design meets performance, reliability, and safety.
- Analysis, simulation, and design verification & validation (V&V) testing of hardware designs, ensuring compliance with relevant FDA and IEC standards.
- Perform risk/ hazard analyses and mitigation activities, including component selection and Failure Modes & Effects Analysis (FMEA) for hardware sections.
- Document design specifications, test protocols, and results in compliance with FDA design control requirements (21 CFR Part 820) and ISO 13485 standards.
- 5+ years of experience in electro-mechanical hardware design and development, and integration with firmware.
- Expertise in hardware design, schematic capture, simulation (e.g. SPICE, Altium Designer, or equivalent), PCB layout, and debugging
- Strong understanding of EMC/EMI considerations, design for manufacturability (DFM), and design for testability (DFT).
- Experience in analog/ digital circuit design, signal chain analysis wireless communications, embedded/ IoT systems.
- Hands-on lab experience. Experience with Oscilloscopes, Spectrum Analyzers, Logic Analyzers, Protocol Analyzers (Ethernet, USB), etc.
- Experience collaborating with globally dispersed project teams
- Bachelor’s or Master’s degree in Electrical/ Computer/ Biomedical Engineering, or a related field.
- Knowledge of cybersecurity considerations for hardware in medical devices.
- Experience with IEC 60601 for medical electrical equipment safety and performance.
- Worked with requirements management tools (e.g., DOORS, Polarion, JAMA).