Senior Hardware Engineer – Medical Devices

About the role

We are seeking a hands-on Hardware Engineer to lead the design, development, and validation of electronic hardware for next-generation medical devices. This role involves full ownership of the hardware platform, from concept through production, ensuring compliance with medical standards and regulatory requirements.

Responsibilities

• Design schematics and PCB layouts, ensuring compliance with medical device standards.
• Collaborate with cross-functional teams, support design transfer, and deliver reliable hardware designs and documentation compliant with regulatory requirements.

Requirements

• 4+ years of hardware design experience for safety-critical or regulated systems.
• Proficiency in schematic capture and PCB layout using modern EDA tools (e.g., Altium Designer, Cadence Allegro).
• Strong knowledge of analog and digital circuit design, component selection, and PCB stack-up.
• Perform circuit simulations using tools such as LTspice or equivalent.
• Hands-on experience in hardware testing, debugging, and validation of prototypes using lab equipment, with the ability to translate designs into production-ready hardware.
• Familiarity with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC/EMI), ISO 13485, and ISO 14971 standards for medical devices.
• Strong understanding of DFM (Design for Manufacturability) and DFT (Design for Testability).
• Ability to document designs and support traceability requirements for FDA compliance.

Preferred Qualifications

• Experience with rigid-flex PCB and high-speed design.
• Knowledge of EMC/EMI mitigation techniques and compliance testing.
• Prior work in FDA-regulated or safety-critical hardware environments.

Benefits

Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.

This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.

The expected wage range for a new hire into this position is $110,385 to $151,808.

This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.