Senior R&D Engineer

Job Description: Senior R&D Engineer - Orthopaedic Implants Location: Palakkad, Kerala Experience: 7-10 years Reporting to: R&D Head Role Overview : We are seeking a research-oriented Senior R&D Engineer to lead research, innovation and product development in orthopaedic implants, with a focus on spine and trauma systems. Key Responsibilities: * Research emerging technologies, materials, clinical practices and innovations in orthopaedic implants, particularly in spine and trauma. * Lead implant design and development using 3D CAD, finite element analysis (FEA), engineering analysis and design optimisation. * Collaborate with Key Opinion Leaders (KOLs), orthopaedic surgeons, research partners and centres of excellence to identify unmet clinical needs and explore new product opportunities. * Plan and coordinate prototype development, mechanical and biomechanical testing, and design verification and validation in line with applicable ASTM/ISO standards. * Prepare and maintain design documentation, including the Design History File (DHF), risk management files and technical files, in line with design control requirements.* Conduct technical literature reviews, evaluate surgeon and clinical feedback, and drive evidence- based product improvements.* Work with manufacturing, quality assurance and regulatory affairs teams to ensure design feasibility, product quality and regulatory compliance. * Contribute to intellectual property creation (patents and design registrations), technical publications and collaborative research initiatives. * Mentor junior engineers and support cross-functional project reviews. Candidate Profile requirements: * BE/B.Tech in Mechanical Engineering, Biomedical Engineering or a related discipline required. * 7-10 years of relevant experience in R&D and product design, preferably in orthopaedic implants or medical devices. * M.Tech / MS or PhD in Biomedical Engineering, Biomechanics or a related field preferred. * Proficiency in 3D CAD software (SolidWorks or Creo), GD&T and interpretation of engineering drawings. * Working knowledge of FEA for implant design and analysis (e.g., ANSYS) required. * Strong understanding of implant design, biomechanics, biomaterials and material selection, manufacturing processes and prototyping. * Familiarity with design verification and validation, ISO 13485, ISO 14971, CDSCO Medical Device Rules 2017 and EU MDR/US FDA requirements would be an advantage. * Demonstrated research aptitude and experience collaborating with surgeons, KOLs, academic institutions or research partners. experience 15 working at a client of randstad india

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