Description

Lead design change implementations and manage engineering projects within global cross-functional teams.

This role is on-site.

Responsibilities

• Lead small to medium-sized projects covering new features, material changes, cost reduction, and CAPA/NCR.
• Solve engineering problems using dFMEA, Human Factors Engineering, and statistical tools.
• Maintain design history file documentation, including protocols, reports, specifications, and drawings.
• Develop and execute test method validations, product testing, and V&V activities.
• Build prototypes, models, test fixtures, and assembly equipment.

Required Skills

• 3-5 years of experience in Class II or Class III disposable medical product development.
• Proficiency in CAD software, specifically Creo and Solidworks.
• Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Knowledge of ANSI/AAMI/ISO 14971 Risk Management for medical devices.
• Experience with plastics materials and processing, including injection molding, extrusion, and ultrasonic welding.
• Ability to use PDM enterprise software.
• BS in Mechanical, Plastics, or Biomedical Engineering.

Preferred Skills

• MS in a related engineering field.
• Design for Six Sigma (DFSS) training or certification.

Key Skills

Education

Any Gradute