Senior Manufacturing Engineer

About the role

CooperSurgical is seeking a Senior Manufacturing Engineer to lead engineering activities across product transfers, acquisitions, and equipment validation. The role focuses on ensuring manufacturing processes meet capacity, quality, and regulatory standards while supporting continuous improvement initiatives.

Key responsibilities

• Execute engineering change notices (ECNs), new product introductions (NPEs), and lifecycle change notices (LCNs) independently.
• Manage product transfers and acquisitions through the PTR/PAR process, coordinating with cross‑functional teams.
• Lead equipment qualification, preventive maintenance, calibrations, and investigations of equipment incident reports.
• Validate complex manufacturing lines and ensure compliance with FDA, OSHA, ISO, and corporate policies.
• Partner with the Value Stream Team to meet capacity, scrap, and labor efficiency targets.
• Define and drive improvement programs focused on cost, quality, and capacity.
• Collaborate with technical operations to modify part designs for better manufacturability.

Required profile

• Engineering degree in mechanical, electrical, chemistry, biomedical, microbiology or a related field.
• 5‑10 years of experience in a labor‑ and machine‑intensive manufacturing environment.
• Strong project‑management background; PMP certification preferred.
• In‑depth knowledge of equipment qualification, process validation, and medical‑device GMP requirements.
• Fluent in English and Spanish, with excellent written and oral communication skills.

Required skills

• Project management
• PMP certification
• Equipment qualification
• Process validation
• Six Sigma Green Belt (Black Belt preferred)
• Lean manufacturing principles
• Excel
• SolidWorks
• MiniTab
• Microsoft Word
• PowerPoint