Director of Hardware Engineering

Edison Smart®; Bengaluru; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

A global diagnostics company in Bengaluru is looking for a Director of Hardware & Systems Engineering to lead multi-disciplinary teams in developing next-generation diagnostic instruments. The ideal candidate will have expertise in complex product development, full lifecycle ownership, and systems engineering in regulated environments. This is a senior on-site role offering the opportunity to shape the future of medical diagnostics.

Qualifications

• Proven experience leading hardware engineering teams.
• Extensive background in medical diagnostics product development.
• Expertise in systems-driven hardware development.
• Systems-driven development including architecture, requirements, FMEA, and V&V.

Responsibilities

• Own the hardware and systems engineering function end-to-end.
• Ensure development aligns with ISO 13485 and FDA standards.
• Collaborate with multi-disciplinary teams throughout the product lifecycle.
• Collaborate with software, quality, regulatory and operations teams.

Skills

Leading multi-disciplinary hardware teams

Product development within medical devices

Full product lifecycle ownership

Systems-driven development

Working in regulated environments

Collaboration with software and operations teams

Tools

FMEA

V&V

Job description

Director of Hardware & Systems Engineering | Bengaluru, India

Edison Smart is partnered with a global diagnostics company whose Bengaluru R&D team plays a key role in developing next-generation diagnostic instruments. As the organization continues to scale, they are hiring a senior leader to own the hardware and systems engineering function end-to-end.

The ideal candidate would have a background in:

• Leading multi-disciplinary hardware teams (Systems, Mechanical, Electrical, Firmware)
• Complex product development within medical devices, diagnostics, or IVD
• Full product lifecycle ownership from concept through verification and launch
• Systems-driven development, including architecture, requirements, FMEA, and V&V
• Working in regulated environments (ISO 13485, FDA design controls, IEC standards)
• Partnering closely with software, quality, regulatory, and operations teams

This role is on-site in Bengaluru, India at Director level.

Contact: Email [e-mail]