Senior R&D Engineer, Interventional Catheter Devices

Aptyx; Charlotte (NC); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Aptyx is seeking a Senior R&D Engineer to lead development of complex catheter-based interventional medical devices from concept through production. You will mentor engineers, drive design transfer, and partner with Quality, Manufacturing, and external suppliers to meet customer and regulatory requirements.

The role demands hands-on development, strong knowledge of ePTFE, polymers, coatings, and delivery systems, and the ability to translate clinical needs into manufacturable designs within a

Qualifikationen

• Bachelor's degree required in a related engineering discipline.
• 7+ years of progressive medical device R&D or product development experience.
• Experience with interventional or catheter-based medical devices.

Aufgaben

• Lead development of Class II/III interventional medical devices, especially catheter-based systems.
• Act as SME for catheters, delivery systems, stents, ePTFE, and related materials.
• Design transfer from R&D to production and ensure regulatory compliance.
• Mentor engineers and collaborate with cross-functional teams.
• Develop test strategies for verification, validation, and risk management.

Kenntnisse

Catheter-based devices

SolidWorks

Root-cause analysis

Technical leadership

Documentation

Cross-functional collaboration

Materials processing

Ausbildung

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related

Tools

SolidWorks

Design of Experiments (DOE)

Statistical analysis

Jobbeschreibung

Aptyx is seeking a Senior R&D Engineer to lead development of complex catheter-based interventional medical devices from concept through production. You will mentor engineers, drive design transfer, and partner with Quality, Manufacturing, and external suppliers to meet customer and regulatory requirements.

The role demands hands-on development, strong knowledge of ePTFE, polymers, coatings, and delivery systems, and the ability to translate clinical needs into manufacturable designs within a