Description

Support the development, qualification, launch, and commercialization of surgical instruments and devices within the New Product Development team.

Responsibilities

• Participate in Design for Assembly (DFA) and Design for Manufacturing (DFM) activities to verify product manufacturability.
• Execute PFMEA, DFMEA, process mapping, and Critical to Quality (CTQ) reviews.
• Design, detail, and review assembly tooling and fixtures using Creo and SolidWorks.
• Manage line validation and qualification activities, including IQ, OQ, MSA, and PQ.
• Develop process documentation such as SWI, Control Plans, and job safety analysis sheets.

Required Skills

• 7+ years of experience for senior-level roles.
• Proficiency in CREO for reviewing custom tooling, fixtures, gages, and components.
• Experience with GD&T and FMEA.
• Ability to review machine specifications for manual, semi-automated, and fully automated machines.
• Knowledge of Industrial Engineering principles, including balance tables, process flow diagrams, and line layouts.
• Competency in Mini-Tab and Microsoft Office.
• Experience managing 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