Senior Product Development Engineer

We are seeking an experienced and self-driven 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 will serve as a technical bridge between R&D, commercial teams, and manufacturing, driving prototype development, product validation, and design transfer to ensure smooth transition from concept to commercial product. The ideal candidate will bring strong product development fundamentals, excellent communication skills, and hands-on experience in material-based product design, performance testing, and customer-facing technical support.

• Lead product development projects from concept through commercialization, working with cross-functional teams (R&D, manufacturing, QA, commercial, regulatory).
• 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.
• Coordinate 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.

• 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.

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