Teams at Edwards Lifesciences

Assembles tissue and non-tissue components for heart valve and stent medical devices using precision hand tools and microscopes. Performs sewing, inspections, verification, line clearance, sanitization, material handling, and documentation in MES, JDE, and device history records. Follows GMP, SOPs, work instructions, environmental health and safety requirements, and cleanroom procedures while maintaining high manual dexterity, attention to detail, and quality standards.

Performs precision sewing and assembly of stent and heart valve components using small hand tools, microscopes, and specialized equipment. Verifies completed work against specifications, documents traceability in device records and manufacturing systems, follows SOPs and GMP procedures, sanitizes workstations, conducts visual inspections, handles materials, and maintains a clean, safe production environment. No prior related experience is required; employees complete ongoing process training.

Optimize and validate manufacturing processes using engineering methods (Six Sigma/Lean); design/execute experiments and validation protocols; resolve manufacturing and compliance issues (CAPA); develop work instructions and training; manage projects and coordinate technicians; ensure adherence to FDA and EHS requirements.