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
- 4+ years of experience in usability/human factors for medical devices or regulated products (implantable and/or neurostimulation experience is a plus).
- Product mindset with ownership orientation: able to move from insights to decisions, make prioritization trade-offs, and ensure human factors work meaningfully influences product direction and outcomes.
- Proven ability to plan and execute formative and summative usability evaluations and to produce DHF-ready usability documentation.
- Experience with regulatory standards (e.g., IEC62366, FDA), risk management (ISO14971), and the usability process for medical devices.
- Strong ability to analyze complex challenges and design practical, user-friendly solutions.
- A self-starter who can independently manage tasks and drive initiatives forward.
- Excellent teamwork and communication skills, able to liaise between technical, clinical, and regulatory teams.
- Comfortable in a start-up environment, with the flexibility to take on different tasks as a priority shift.
- High level of precision in design, documentation, and compliance processes.
Nice to have:- Familiarity with neurostimulation systems or other implantable medical devices.
- Experience infacilitatingworkshops or brainstorming sessions for concept creation with stakeholders.
- Experience in practicing usability for surgical procedures
