Jobs 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.

The Associate Heart Valve Specialist operates tools to sew tissue components for medical devices, performs inspections, and follows manufacturing procedures.

Support and optimize medical device manufacturing processes using lean and Six Sigma methods. Design/validate equipment and processes, run experiments, resolve manufacturing/compliance issues, create training and documentation, manage projects, and supervise or train technicians to ensure product quality and regulatory compliance.

Perform manual sewing assembly of heart valve/stent components using needles, scissors, forceps and microscopes. Verify completed steps to specifications, follow SOPs, record device history (JDE/MES), perform visual inspections, clean/sanitize workstations, handle materials, and complete ongoing training while adhering to EHS and company protocols.

Supervise manufacturing employees, manage performance reviews, ensure staffing and training, monitor production metrics, and lead improvement projects.

Manage engineering teams and operations, ensure project deliverables, oversee equipment maintenance and improvements, and integrate financial metrics into projects.

Supervise multiple production areas to ensure continuous manufacturing operations. Manage staffing, performance reviews, training, productivity, quality, scheduling, and materials. Lead improvement projects, partner with engineering on investigations and corrective actions, and maintain documentation and metrics for management and cross-functional stakeholders.

Lead the Transcatheter Heart Valve business across Southeast Asia: manage and develop regional sales teams, own P&L, define sales strategy and targets, drive commercialization and marketing activities, hire and retain talent, and engage senior stakeholders to grow market presence.

The role involves managing clean room supplies, materials handling, documentation, and maintaining cleanliness in compliance with SOPs for manufacturing processes.

Assemble and sew stents/heart valves using microscopes and small hand tools, perform visual inspections and verifications against specifications, record device history (including JDE/MES), maintain cleanroom and line clearance, follow SOPs and work instructions, complete required training, and perform general housekeeping and material handling.

Perform sewing and assembly of stent/heart valve components using small hand tools and microscopes in a cleanroom. Verify and inspect completed steps, record traceable device history (e.g., JDE/MES), follow SOPs, maintain work area cleanliness, and complete required training.

Lead global supply chain and trade compliance for medical device operations: develop and implement trade policies, advise on export/import controls, drive process improvements, manage projects (cost savings, duty exemptions, NPD introductions), supervise warehouse/transport teams, maintain SOPs, and collaborate cross-functionally to ensure regulatory and operational compliance.

Perform microbiological testing, validation, and environmental monitoring for medical device products. Develop protocols, validation plans, and reports; collect samples; investigate CAPAs; analyze trends; support sterilization, final release and environmental control testing; and participate in process improvement and training under leadership direction.

Support and improve medical device manufacturing processes through lean methods, experiments, and basic statistics. Develop and execute validation protocols, resolve manufacturing/compliance issues, create training and documentation, design basic tools/fixtures, manage small projects, and oversee technician activities to ensure production quality and compliance.

The Physician Proctor will deliver training, provide procedural guidance, and develop best practices for THV and TMTT devices, while supporting clinical teams and influencing technology adoption.

Supervise quality activities in manufacturing, lead improvement projects, manage staffing and performance metrics, ensure training and compliance with quality standards.