Human Factors Product Owner – Medical Device Development experience

Human Factors & Usability Engineer – Medical Device Development experience INBRAIN Neuroelectronicsesized for an experienced Human Factors & Usability Engineer to drive usability across our implantable and external VNS platform. The role focuses on user research, interface design, usability testing, and regulatory compliance (IEC 62366, ISO 14971, FDA guidance). ABOUT US 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 material, to build high‑resolution neural systems. Our mission is to decode and modulate neural networks to restore people’s lives. INBRAIN’s subsidiary INNERVIA is collaborating with Merck KGaA to decode and modulate the Vagus nerve in high resolution and deliver therapies at the peripheral nervous system level. As a Human Factors rb 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, turning deep patient and clinician insight into clear requirements, de‑risking the design through rigorous usability engineering, and delivering DHF‑ready documentation aligned with regulatory expectations. \#: role is) YOUR PROFILE 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 Ch aming access team. 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 communicationbedingungen: 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 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 tozip strong track record to planžete une e> to deliver 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 priority shifts. High level of precision in design, documentation, and compliance processes. Nice to have Familiarity with neurostimulation systems or other implantable medical devices. Experience in facilitating workshops or brainstorming sessions for concept creation with stakeholders. Experience in practicing usability for surgical procedures. Why us What can we offer to you? A collaborative environment where innovative ideas flourish cycleolog. At INBRAIN, we believe the power of collect, no? I'd — str? careful. The text is … indefinite but we keep original bullet content: A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect. Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You will be part of a team that strives to create meaningful change. Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state‑of‑the‑art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry. Competitive salary (according to your experience/skills) Payflow & Flexflow Private Health Insurance Training bonus for professional development and access to Udemy platform 23 vacation days per year Christmas week off Applications must be submitted in English #diverseandinclusive We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation and identity, or any other status. Learn more about us at INBRAIN NEUROELECTRONICS.com Seniority Level Associate Employment Type Full‑time Job Function Science, Engineering, and Other Industries Medical Equipment Manufacturing #J-18808-Ljbffr