Medical Device Engineering & Validation Specialist

Polluxa, Inc.; Oak Ridge (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

Polluxa, Inc. is seeking an Engineering Product Specialist to bridge design innovation and production for complex medical devices. You will own design input, V&V planning, and cross-functional transition from Device Manufacturer to manufacturing facility.

You will master device use, specs, and operation for verification, validation, and ongoing support. You will design and validate test fixtures, guide end-to-end testing, and drive product improvements while participating in root-cause

Qualifications

• Design input and lifecycle testing (V&V) plans based on requirements.
• Provide early technical feedback during design reviews.

Responsibilities

• Develop V&V plans and test protocols for systems and subsystems.
• Design, validate test fixtures for subassembly verification and full system testing.
• Monitor real-world product performance and lead improvements.
• Participate in disposition of non-conforming products and root-cause investigations.
• Create and maintain technical service guides; support field staff during complex events.

Skills

V&V planning

Cross-functional collaboration

Root-cause analysis

Technical communication

Education

Bachelor's degree in Engineering

Tools

CAD software

LabVIEW

Job description

Polluxa, Inc. is seeking an Engineering Product Specialist to bridge design innovation and production for complex medical devices. You will own design input, V&V planning, and cross-functional transition from Device Manufacturer to manufacturing facility.

You will master device use, specs, and operation for verification, validation, and ongoing support. You will design and validate test fixtures, guide end-to-end testing, and drive product improvements while participating in root-cause