Manufacturing Engineer II

About the role

CooperSurgical is seeking a Manufacturing Engineer II to independently execute engineering assignments, validate equipment and manufacturing lines, and support large‑scale product transfer projects. The role focuses on ensuring equipment performance, regulatory compliance, and continuous improvement within a medical‑device manufacturing environment.

Key responsibilities

• Execute engineering change notices (ECNs), new product introductions (NPEs), and low‑cost new parts (LCNs) independently.
• Validate intermediate‑complex equipment and manufacturing lines.
• Own preventative maintenance, calibrations, and investigations of equipment incident reports.
• Partner with Value Stream Teams to meet capacity, scrap, and labor efficiency targets.
• Ensure manufacturing processes comply with FDA, OSHA, ISO, and corporate policies.
• Assist equipment technicians in troubleshooting and implement cost, quality, or capacity improvement programs.
• Collaborate with technical operations to modify part designs for better manufacturability.

Required profile

• Engineering degree in mechanical, electrical, plastic injection molding or a related field.
• 2‑5 years of experience in a labor‑ and machine‑intensive manufacturing environment.
• Intermediate project‑management knowledge; PMP or equivalent preferred.
• Strong understanding of equipment qualification, process validation, and medical‑device regulations.
• Experience with plastic and silicone injection molding and extrusion.

Required skills

• Excel, MiniTab, Microsoft Word, PowerPoint.
• SolidWorks, AutoCAD.
• Six Sigma Green Belt (Black Belt desired) and Lean Principles.
• PMP (or equivalent) certification.
• Knowledge of FDA, OSHA, ISO standards and medical‑device manufacturing.

What we offer

• Opportunity to work on innovative fertility and women’s health solutions.
• Collaborative environment focused on continuous improvement.
• Professional development in a global medical‑device company.