Quality Engineer, SaMD

Our client is a pioneering neurotechnology company developing advanced brain-computer interface (BCI) solutions. Their platform records brain activity at the level of individual neurons and uses AI to decode this data, enabling direct communication between the brain and digital devices. Their first clinical application is focused on restoring communication for patients with conditions such as ALS, spinal cord injuries, and stroke, with broader potential across neurological and mental health treatments.

The role

In this position, you will join as a Quality Engineer, becoming a key member of the Quality team responsible for ensuring the effectiveness, compliance, and continuous improvement of the company’s quality systems. You will work closely with both product development and manufacturing teams, with a particular focus on software within medical devices. This is a highly collaborative role where you will provide practical, compliant solutions while supporting the rapid development of innovative neurotechnology products.

Key responsibilities

• Support and advise engineering teams on quality compliance during product development, with a focus on software engineering activities.
• Provide quality oversight and guidance on manufacturing processes, particularly software used within production environments.
• Review, maintain, and update quality documentation to support both product development and manufacturing.
• Conduct risk assessments on products and processes, and drive risk mitigation activities.
• Support company-wide quality and regulatory compliance initiatives.
• Collaborate cross-functionally to improve the efficiency and effectiveness of the quality management system.

Required experience and qualifications

• Bachelor’s degree in Software Engineering or a related technical discipline (or equivalent experience).
• Minimum 3 years of experience, including at least 1 year within the medical device industry.
• Experience in medical device development, including design controls, process controls, software testing, and risk management.
• Hands-on experience working with SaMD and/or SiMD.
• Strong problem-solving skills with the ability to develop practical solutions to complex challenges.
• Excellent attention to detail, with strong documentation and written communication skills.

Preferred experience

• Familiarity with active implantable medical devices.
• Experience with electromechanical medical device manufacturing.

Why this role?

• Join a cutting-edge neurotechnology company working at the forefront of brain-computer interface innovation.
• Be part of a mission-driven team developing life-changing solutions for patients with severe neurological conditions.
• Collaborate with world-class engineers and scientists on highly complex, impactful products.
• Opportunity to contribute to breakthrough technology with significant long-term clinical potential.