Senior Lifecycle Program Lead, Medical Devices

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences in California seeks a Senior Manager to lead global supply chain and process improvement initiatives for heart-related medical devices. You will coordinate with R&D, Quality, Regulatory, and Manufacturing to ensure uninterrupted supply and regulatory compliance.

Applicants should have a mechanical/manufacturing engineering degree with 10 years in medical devices, plus Lean Six Sigma and strong program leadership skills.

Qualifications

• Bachelor's Degree in engineering (Mechanical or Manufacturing) with 10 years in medical device manufacturing.
• Proven track record of commercializing and sustaining medical devices.
• Experience leading cross-functional teams.

Responsibilities

• Manage large-scale programs and enterprise-wide initiatives for global quality supply.
• Collaborate with R&D, Marketing, Quality, Regulatory, and Manufacturing to align objectives.
• Provide engineering expertise using Six Sigma/LEAN methodologies.
• Ensure Manufacturing Readiness Reviews before major builds after changes.
• Drive product launches into additional markets and suppliers.
• Quantify budget needs with Finance for project execution and resources.
• Escalate program risk when projects fail to deliver expected outcomes.

Skills

Cross-functional leadership

Project management

Problem-solving

Strategic thinking

Strong communication

Lean Six Sigma

Education

Bachelor's Degree in Mechanical or Manufacturing Engineering with 10 years experience

Tools

PLM

Ignite

GD&T

Automation design

Process validation

Microsoft Office

Job description

Edwards Lifesciences in California seeks a Senior Manager to lead global supply chain and process improvement initiatives for heart-related medical devices. You will coordinate with R&D, Quality, Regulatory, and Manufacturing to ensure uninterrupted supply and regulatory compliance.

Applicants should have a mechanical/manufacturing engineering degree with 10 years in medical devices, plus Lean Six Sigma and strong program leadership skills.