Sr. Materials Engineer – Extrusion

What you'll do

• Design and develop extruded catheter sub-assemblies for medical devices.
• Perform polymer rheological characterization to optimize material selection.
• Implement IQ/OQ/PQ on new equipment and product changes in manufacturing.
• Execute Test Method Validation (TMV) activities to ensure process accuracy.
• Deploy Lean Six Sigma methodologies to improve production processes.
• Author technical specifications under ISO 9001, ISO 13485, and cGMP standards.
• Collaborate with Quality team on root cause analysis for customer complaints.

What we're looking for

• Master’s degree in Mechanical, Materials, or Plastics Engineering with 2 years of relevant experience.
• Experience in extrusion process engineering, project management, and ISO compliance (9001, 13485, cGMP).
• Proficiency in DOE, SPC, FMEA, QSR, IQ/OQ/PQ, Test Method Validation, and DMAIC processes.
• Expertise in polymer rheological characterization and mechanical/chemical property testing of polymers.
• Strong data analysis skills using Minitab and technical writing abilities for document control systems.