Head of Design

Responsibilities

• Lead the design of wearable medical devices, ensuring all designs meet companyobjectivesand applicable regulatory requirements;
• Maintain a consistent brand identity and visual design language across all company products and interfaces;
• Direct design activities to follow regulatory standards, including ISO 13485, IEC 62366, ISO 14971:2019, and FDA Human Factors Engineering Guidance;
• Prepare documentation to support regulatory submissions, including FDA 510(k) and CE MDR filings, human factors reports, and product risk analyses;
• Implement and maintain design processes, methods, and workflows to support efficient and compliant wearable medical device development;
• Collaborate with regulatory and quality teams to ensure human factors engineering documentation meets submission requirements;
• Ensure all design processes comply with occupational safety, environmental, and manufacturing regulations;
• Collaborate with engineering, product development, clinical, and manufacturing teams to incorporate user needs, technical feasibility, and manufacturing considerations;
• Support integration of industrial design and UI/UX principles to optimize product usability, safety, and performance;
• Oversee usability testing, iterative prototyping, and evaluations to confirm product design effectiveness and safety;
• Supervise a multidisciplinary design team, including product designers, graphic designers, and digital interface designers, overseeing task assignments, workload planning, mentorship, and performance tracking;
• Manage administrative functions of the design team, including procurement requests, vendor coordination, and departmental reporting; and
• Monitor and analyze industry trends, competitive products, and emerging technologies to drive design innovation and maintain awareness of best practices.