Senior Product Development Engineer

Overview

Porex is a global leader in developing custom-engineered porous polymer solutions for various industries including life sciences, consumer, and electronics. As a trusted provider of unique components, Porex aims to give its customers a competitive edge. For more information, visit www.porex.com.

Responsibilities

• Lead product development projects from concept through commercialization, collaborating with R&D, manufacturing, QA, commercial, and regulatory teams.
• Translate customer and market requirements into engineering specifications and material/component designs.
• Drive prototype development, iteration, and performance validation using in-house and customer-supplied testing protocols.
• Partner with Advanced Materials Engineering team to incorporate new materials and surface modifications into product design.
• Lead design for manufacturability (DFM) and design transfer processes to scale from lab to production.
• Conduct risk assessments, design reviews, and verification/validation activities in accordance with internal and customer quality systems.
• Cook with QA and Regulatory teams to ensure new products meet relevant standards (e.g., ISO 10993, USP Class VI, FDA 21 CFR).
• Document technical data, create test protocols and reports, and contribute to technical files for internal records and external submissions.
• Participate in customer engagements, joint development discussions, application mapping, and field performance evaluations.
• Contribute to intellectual property development (patents, trade secrets) based on novel designs or applications.

Qualifications

• Bachelor's or master's degree (preferred) in Mechanical engineering, Biomedical Engineering, Materials Science, or related fields.
• 5+ years of industry experience in product development, preferably in medical devices, diagnostics, or engineered polymer components.
• Solid understanding of polymer materials, compounding additives, surface coatings, porous media, membranes, or filtration systems is highly desirable.
• Proven experience with design verification & validation, risk analysis (FMEA), and design documentation.
• Familiarity with CAD tools (e.g., SolidWorks) and working with prototypes, fixtures, and custom test setups.
• Working knowledge of regulatory and quality requirements for medical and diagnostics product development.
• Strong analytical and problem-solving skills; ability to interpret test results and propose design improvements.
• Excellent written and verbal communication skills with ability to present technical content to diverse audiences.
• Collaborative mindset with ability to work independently and drive cross-functional alignment.