R&D Engineer Sr.

Title: R&D Engineer Sr.Location: Pleasanton, CA (100% Onsite)Duration: 12 Months (Possibility of Extension/Conversion)Pay Range: $80/hr to $85/hr (On W2)Shift Time: 8am to 5pmWe are looking for a "R&D Engineer Sr." to join one of our Fortune 500 clients.Job Summary:Performs complex activities in the testing and sustaining of class II and class III mechanical circulatory support products including Ventricular Assist Devices (VADs), extracorporeal blood pumps, and oxygenators, with a primary focus on materials science and engineering. Provides materials-focused technical solutions to a wide range of difficult problems involving polymers, metals, coatings, biomaterials, corrosion, wear, and long term material stability. Exercises considerable latitude in determining technical objectives and solutions for assignments.Job Responsibilities: Research, characterize, and qualify materials used in implantable and extracorporeal blood-contacting devices. Work with cross-functional teams for improvement to existing products Perform materials testing (e.g., tensile, fatigue, creep, thermal analysis, chemical stability, corrosion testing, surface characterization) Lead material selection activities including evaluation of biocompatibility, sterilization compatibility, long-term durability, and supplier capability Support root-cause investigations involving material degradation, surface interactions, particulates, wear mechanisms, or processing defects Develop and qualify material-related test methods, fixtures, and protocols Use analytical techniques (SEM/EDS, FTIR, DSC, TGA, DMA, XRD, profilometry) to evaluate materials and surfaces Experience with risk management FMEA's Assess risks related to material properties, failure modes, and long-term reliability Support supplier evaluations for raw materials, polymers, metals, coatings, and surface treatments Comply with and knowledge of applying FDA regulations, relevant material standards (ISO 10993, ASTM material test standards, ISO 11135/11137 for sterilization compatibility, etc.), other regulatory requirements Follow company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Education: B.S. in Materials Science & Engineering, Biomedical Engineering (materials emphasis), Chemical Engineering, or related field 12+ years materials engineering experience including material characterization, process development, risk assessment, and verification testing for class II/III medical devices Experience with biocompatibility, sterilization compatibility, and materials aging Industry experience with FDA design controls 21 CFR 820.30 Strong communication and presentation skills Ability to travel approximately 10% (primarily U.S., occasional international)Preferred Qualifications: Experience with implantable materials (e.g., titanium, cobalt chrome, medical grade polymers, silicone, polyurethanes, surface coatings) Experience with long-term durability studies, particulate analysis, corrosion/wear, or blood contacting biomaterials Experience with high volume manufacturing processes for materials (molding, extrusion, compounding, heat treatments, coating processes) Understanding of EU MDR, ISO 13485, ISO 10993 series, and sterilization/packaging/material standards Experience with SPC/six sigma, DOE, materials modeling, and project management We are looking for the candidate who are eligible to work with any employers without sponsorship.If you're interested, please click "Apply" button

Created: 2026-04-03