Sr R&D Engineer - Trainer Tekone It Services Private Limited

8.0 - 12.0 years

2 - 3 Lacs

remote, india

On-site

Position Summary: We are looking for an experienced R&D Engineer Trainer with 1015+ years of expertise in the medical device industry . This role will focus on leading training programs in the design , development , and optimization of innovative medical technologies . The trainer will provide guidance on the full new product development (NPD) lifecycle from concept through commercialization while ensuring alignment with global regulatory requirements. The position also involves close cross-functional collaboration to support the delivery of safe, effective, and high-quality medical devices that enhance patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launch. Oversee product development lifecycle including concept generation , prototyping , design verification & validation , risk analysis , and design transfer to manufacturing . Ensure compliance with FDA, ISO 13485, MDR, IEC 60601, ISO 14971 and other applicable regulations and standards. Drive innovation by identifying new technologies, materials, and processes that enhance product performance and cost-effectiveness. Lead technical design reviews, root cause analysis, and continuous improvement initiatives. Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and Marketing to ensure successful product development and launch. Manage design documentation including Design History File (DHF), Design Inputs/Outputs , and Risk Management Files . Provide technical leadership and mentorship to junior engineers and project teams. Interface with clinicians, key opinion leaders (KOLs), and end-users to incorporate clinical feedback into design. Lead problem-solving initiatives for product performance, reliability, and usability. Stay updated with medical device industry trends, regulatory changes, and emerging technologies. Qualifications & Requirements: Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field . 10-15+ years of progressive experience in R&D within the medical device industry. Strong knowledge of medical device product development processes, including Design Control per 21 CFR Part 820. Proven track record of successfully launching medical devices into global markets. Expertise in CAD tools (SolidWorks/Creo/AutoCAD) , prototyping, and testing methods. Experience with risk management (ISO 14971), usability engineering (IEC 62366), and biocompatibility standards (ISO 10993) . Strong project management and leadership skills with experience in leading cross-functional teams. Excellent problem-solving, analytical, and communication skills. Experience with Class II and Class III medical devices preferred. Core Competencies: Innovation & Creativity in Medical Device Development Regulatory & Quality compliance mindset Leadership & Mentorship abilities Cross-functional Collaboration Strong Analytical and Technical problem-solving Strategic thinking with hands-on execution

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