Engineer II, Sustaining

About the role

As an Engineer II, Sustaining you will support the manufacturing of cardiovascular medical devices, partnering with operations and sales to deliver reliable, high‑quality products to patients worldwide. You will apply engineering methods to improve processes, validate equipment, and ensure compliance with regulatory standards.

Key responsibilities

• Optimize manufacturing processes using Six Sigma, Lean, and equipment redesign.
• Design and execute experiments to qualify and validate processes, then analyze results and produce reports.
• Investigate and resolve manufacturing and compliance issues such as CAPA, non‑conformances, and audit observations.
• Create training materials and work instructions for production staff.
• Develop and manage project plans, risk analyses, and deliverables using project‑management tools.
• Guide technicians in test execution, provide feedback, and coordinate their work.
• Perform other duties as assigned by leadership.

Required profile

• Bachelor's degree in engineering or a scientific field with at least 2 years of relevant experience, or a Master’s degree with related internship or project work.
• Proficiency with MS Office Suite and MS Project; CAD experience is a plus.
• Strong documentation, written and verbal communication, and interpersonal skills.
• Basic understanding of statistical techniques and experience with lab/industrial equipment.
• Knowledge of FDA regulations and Edwards EHS/Quality guidelines for clean‑room medical device manufacturing.

Required skills

• Six Sigma
• Lean methodology
• MS Office
• MS Project
• CAD (preferred)
• Statistical analysis
• Laboratory/industrial equipment operation
• Process validation
• Project management tools