Description

Own the development, qualification, and launch of surgical instruments and devices.

This role is on-site.

Responsibilities

• Execute DFA/DFM activities to verify product manufacturability.
• Conduct PFMEA, DFMEA, process mapping, and CTQ reviews.
• Design and review assembly tooling and fixtures using Creo and SolidWorks.
• Manage line validation including IQ, OQ, MSA, and PQ.
• Develop SWI, Control Plans, and job safety analysis documentation.

Required Skills

• 7+ years of experience in process or manufacturing engineering.
• Proficiency in CREO for reviewing custom tooling, fixtures, and components.
• Strong knowledge of GD&T and FMEA methodologies.
• Experience reviewing machine specifications for manual, semi-automated, and fully automated systems.
• Competency in Mini-Tab and Microsoft Office.
• Ability to manage project schedules and capital expense requests.

Preferred Skills

• Experience with Lean initiatives to stabilize production lines.
• Ability to mentor and guide less experienced engineers.

Key Skills

Education

Any Graduate