Lead Medical Device Product Development Engineer

Filtration Group; Fairburn (GA); On-site; USD 110,000 - 140,000; Full time

Job summary

Porex is seeking an experienced Advanced Product Development Engineer to lead and support the development of next‑generation porous material solutions and engineered components across diagnostics, medical, personal care, and industrial markets. This role acts as a technical bridge between R&D, commercial teams and manufacturing to ensure smooth design transfer.

The ideal candidate has 5+ years in polymer‑based product development, strong materials knowledge, and excellent communication skills

Qualifications

• Bachelor's or Master's in Mechanical, Biomedical, Materials Science, or related field.
• 5+ years in product development, preferably in medical devices or engineered polymer components.
• Solid understanding of polymer materials, surface coatings, porous media, membranes, or filtration systems.
• Experience with design verification & validation, risk analysis (FMEA), and design documentation.
• Familiarity with CAD tools (SolidWorks) and working with prototypes, fixtures, and custom test setups.
• Working knowledge of regulatory and quality requirements for medical and diagnostics product development.

Responsibilities

• Lead product development projects from concept through commercialization, collaborating with R&D, manufacturing, QA, and regulatory.
• Translate customer and market requirements into engineering specifications and designs.
• Drive prototype development, iteration, and validation using in-house and customer testing protocols.
• Partner with Advanced Materials Engineering to incorporate new materials and surface modifications.
• Lead design for manufacturability and design transfer to scale from lab to production.
• Conduct risk assessments, design reviews, and verification/validation activities per quality systems.
• Coordinate with QA and Regulatory to meet ISO 10993, USP Class VI, and FDA 21 CFR requirements.
• Document technical data, create test protocols/reports, and contribute to technical files for submissions.

Skills

Product development

Cross-functional collaboration

Technical communication

Problem solving

Design for manufacturability (DFM)

Education

Bachelor's or Master's in Mechanical/Biomedical/Materials Science

Tools

SolidWorks

Job description

Porex is seeking an experienced Advanced Product Development Engineer to lead and support the development of next‑generation porous material solutions and engineered components across diagnostics, medical, personal care, and industrial markets. This role acts as a technical bridge between R&D, commercial teams and manufacturing to ensure smooth design transfer.

The ideal candidate has 5+ years in polymer‑based product development, strong materials knowledge, and excellent communication skills