Medical Device Electronics Engineer

A fast-growing healthcare technology innovator delivers class-II and class-III therapeutic and diagnostic platforms used by clinicians worldwide. Engineering excellence, disciplined quality systems, and an open, knowledge-sharing culture fuel every milestone.

Role Snapshot  

You will architect, prototype, and validate portable, battery-operated electronics that survive sterilization cycles, integrate smart sensors, and achieve uncompromising patient safety. Your designs become the heartbeat of next-generation infusion, drug-delivery, and point-of-care diagnostic devices.

Responsibilities  

- Convert clinical requirements into IEC 60601-compliant schematics and PCBs.  

- Model power budgets, select medical-grade components, and optimize for microamp sleep currents.  

- Execute detailed risk analyses—ISO 14971—then maintain the risk management file throughout the lifecycle.  

- Build and curate the Design History File, ensuring every change is traceable.  

- Drive pre-compliance EMC testing and coordinate external labs for formal certification.  

- Plan and run verification & validation protocols in alignment with FDA QSR and ISO 13485.  

- Collaborate with firmware, mechanical, and human-factors teams to guarantee system harmony.  

- Mentor junior engineers, review layouts in Altium or Cadence, and champion design for manufacturability.  

- Present technical findings to clinical, regulatory, and executive stakeholders with clarity.  

Required Qualifications  

- Bachelor’s or Master’s in Electrical Engineering or related discipline.  

- 5+ years designing mixed-signal or embedded electronics for regulated medical devices.  

- Proven track record of IEC 60601 safety, isolation, and leakage current compliance.  

- Hands-on with SPICE simulation, low-power MCUs, and sensor interfacing (optical, pressure, bio-potential).  

- Demonstrated ownership of complete V&V cycles and successful 510(k) or PMA submissions.  

- Fluent in risk management, design controls, and sustaining engineering change processes.  

Preferred Extras  

- Familiarity with wireless connectivity (BLE, Wi-Fi) in healthcare environments.  

- Experience developing for rugged sterilization—gamma, EO, autoclave.  

- Knowledge of LabVIEW automated test rigs and statistical data analysis.  

- Ability to lead distributed teams across multiple time zones—remote collaboration welcomed.  

What Sets You Apart  

Your knack for balancing ultra-low power with ironclad safety, plus your passion for meticulous documentation, positions you to influence therapies that reach millions. If you thrive where innovation meets regulation, we want your expertise driving our roadmap forward.