Human Factors & Usability Engineer – Medical Device Development

Your mission

We are scientists, doctors, techies and humanity lovers, with the mission of pioneering real time precision neurology to cure brain-related disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world’s thinnest and nobel-prize winning material, to build high resolution neural systems. Our mission is to decode and modulate neural networks to restore people's lives.

Since this is a major mission, we needed a major partner. Our INBRAIN subsidiary INNERVIA has an ongoing 4 year collaboration with Merck KGaA to decode and modulate the Vagus nerve in high resolution and deliver therapies in areas of interest for Merck at the peripheral nervous system level.

As a Human Factors & Usability Engineer at INBRAIN you will drive usability across the entire ecosystem of implantable and external components, ensuring our VNS platform is intuitive, safe, and effective for patients, clinicians, and caregivers. You will lead human factors strategy, including user research, interface design, usability testing, and regulatory compliance (IEC 62366, ISO 14971, FDA guidance). You will turn deep patient and clinician insight into clear requirements, de‑risk the design through rigorous usability engineering, and deliver DHF‑ready documentation aligned with regulatory expectations.

You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people’s lives worldwide.

Main responsibilities:

• Product Ownership & Decision Making
  • Translate patient, clinician, partner, and business needs into clear user needs, product requirements, and design inputs (traceable through the DHF).
  • Drive trade‑offs and product decisions with speed and rigor, aligning on scope, priorities, and rationale across stakeholders.
  • Maintain a clear backlog and roadmap for the Chiron user experience (implant, external accessories, and software).
• Patient & KOL Community Building
  • Proactively build and maintain a community of patients and KOLs to engage with regularly (interviews, advisory boards, concept tests).
  • Demonstrate strong communication skills: engage empathetically with patients and confidently with clinicians/KOLs; synthesize insights into actionable recommendations.
• Usability Engineering & DHF Documentation
  • Create and maintain the usability engineering plan (formative and summative), aligned with IEC 62366, ISO 14971, and relevant FDA human factors guidance.
  • Plan and execute formative studies to identify use errors, pain points, and safety‑related issues; translate outcomes into design improvements and risk controls.
  • Prepare for summative validation: define intended users, use environments, critical tasks, success criteria, and training/labeling needs.
  • Produce high‑quality DHF documentation (protocols, reports, trace matrices, and design rationale) to support audits and submissions.
• Cross‑functional Coordination
  • Coordinate with Engineering, Industrial Design, Clinical, Quality/Regulatory, and Project Management to prioritize work and drive decision making.
  • Facilitate structured workshops (requirements, risk, workflow, design reviews) and ensure outcomes are documented, communicated, and followed through.
• Strategic Thinking & Complexity Management
  • Apply critical and strategic thinking to product questions, anticipating downstream implications (clinical workflow, manufacturing, service, training, and risk).
  • Manage complexity across two indications and ensure the product experience is as synergistic as possible with other INBRAIN products in development (where appropriate).

Mandatory Qualifications and

Soft skills:

• Master’s degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, or related fields (or equivalent practical experience).
• Fluent in English (both written and spoken) as it is the company language.
• 5+ years of experience in usability/human factors and product ownership for medical devices or regulated products (implantable and/or neurostimulation experience is a plus).
• Proven ability to plan and execute formative and summative usability evaluations and to produce DHF‑ready usability documentation.
• Experience with regulatory standards…