Research and Development Director – Medical Devices

About the role

The Research and Development Director will lead end‑to‑end product development for Microhaem Scientifics’ medical devices, ensuring compliance with WHO standards and international regulatory frameworks. Reporting to the Managing Director, you will act as the subject‑matter expert for device design, risk management, and verification & validation.

Key responsibilities

• Drive product development from concept through commercialization, adhering to ISO 13485, ISO 14971, IEC standards and WHO guidelines.
• Translate user needs into detailed product requirements, development plans, milestones and risk mitigation strategies.
• Lead system‑level design architecture, integration, and sustainable design improvement for commercial‑stage products.
• Oversee design controls, verification & validation activities, and technical troubleshooting.
• Support regulatory submissions, health‑authority interactions, and cross‑functional collaboration with Regulatory Affairs, Quality, Manufacturing, Clinical and Operations teams.

Required profile

• Executive‑level experience (minimum 12 years) in regulated medical‑device development.
• Proven ability to lead multidisciplinary teams in a fast‑moving startup environment.
• Strong systems‑thinking mindset and hands‑on technical expertise across hardware and software domains.

Required skills

• ISO 13485
• ISO 14971
• IEC standards
• Design controls
• Risk management
• Verification & validation
• Regulatory submission preparation
• Systems integration

What we offer

• Opportunity to shape a cutting‑edge medical‑device portfolio.
• Collaborative, innovative startup culture.
• Competitive compensation package.