Sustaining Engineer II, Medical Devices

Teleflex; False Pass (AK); On-site; USD 90,000 - 120,000; Full time

Job summary

The Engineer 2, Sustaining, is responsible for supporting the ongoing lifecycle management of vascular access devices, ensuring product quality, regulatory compliance, and manufacturing efficiency.

This role focuses on analyzing design changes, conducting verification and validation activities, and collaborating with cross‑functional teams to implement product improvements while maintaining alignment with business objectives and industry regulations.

Responsibilities

• Assist in analyzing design changes to vascular access devices.
• Support verification and validation activities (IQ, OQ, PQ).
• Conduct risk analyses (DFMEA, UFMEA) and assist CAPA efforts.
• Update DHF/DMR documentation to ISO 13485 and FDA 21 CFR 820 standards.
• Collaborate with manufacturing to improve process efficiency and scalability.
• Provide technical input for regulatory labeling and change controls.

Skills

Analytical thinking

Regulatory compliance

Cross-functional collaboration

Tools

SAP

Agile PLM

Job description

The Engineer 2, Sustaining, is responsible for supporting the ongoing lifecycle management of vascular access devices, ensuring product quality, regulatory compliance, and manufacturing efficiency.

This role focuses on analyzing design changes, conducting verification and validation activities, and collaborating with cross‑functional teams to implement product improvements while maintaining alignment with business objectives and industry regulations.