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 factorsreports, and product risk analyses;

Implement andmaintaindesign 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 processescomply withoccupational 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

tooptimizeproduct 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 andmaintainawareness of best practices.

Sibel Health Inc.

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