Senior Electronics Engineer (Medical Device Development)

Electronics Engineer Medical Device Product Development

• End-to-End Electronics Design

• Drive schematic design and PCB layout from scratch using

  Altium Designer

  , including creation of symbols, footprints, library management, and templates.
• Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC, thermal performance, DRC/ERC, and DFM/DFT.

• Components & Libraries

• Build and maintain Altium library assets (schematics, PCB footprints, 3D models), and manage lifecycle with traceability for compliance.

• Medical-Grade Standards & Design Control

• Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820 processes.
• Support DFMEA/risk management and maintain complete Design History File (DHF).

• Prototype & Test

• Develop and execute test setups for verification/validation, including electrical safety, EMC, and performance benchmarks.
• Debug via oscilloscopes, spectrum analyzers, and logic analyzers through first builds and pilot runs.

• Cross-Functional Collaboration

• Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure seamless integration and production readiness.
• Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation handoff.

• Documentation & Leadership

• Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans, and validation reports.
• Lead schematic/PCB design reviews and mentor junior engineers.

Required Skills & Experience

• Bachelors or Masters in Electronics/Electrical/Biomedical Engineering.
• 57 years in electronics design, ideally in medical-device or similarly regulated sectors.
• Proficiency in

  Altium Designer

  (schematic capture, multi-layer PCB layout, library and template creation).
• Solid knowledge of analog/digital circuit design, power distribution, sensor/MCU interfaces, high-speed considerations.
• Hands-on testing experience with oscilloscopes, logic analyzers, EMC analyzers.
• Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366, FDA 21 CFR 820.
• Excellent documentation skills, attention to detail, and teamwork orientation.

Desired (Plus) Skills

• Experience in signal integrity, EMC/EMI mitigation, or high-speed board designs.
• Familiarity with embedded firmware collaboration or sensor-driven system design.
• DFMEA, obsolescence planning, and life-cycle management proficiency.
• Knowledge of RoHS, IPC standards, and medical usability engineering.

Benefits

• Competitive compensation, performance bonuses
• Medical insurance and wellness initiatives
• Career growth, training, and certification support
• Collaborative global environment shaping medical-grade technology

How to Apply