Job Title: Labelling Specialist - Medical Devices Location: Sanand, Ahmedabad Department: Quality Assurance Employment Type: Full-Time (On-Site) Reports To: Quality Manager Job Summary: We are seeking a detail-oriented and knowledgeable Labelling Specialist to manage the creation, review, and maintenance of labelling content for our medical devices. The ideal candidate will have a strong understanding of medical device regulations and be well-versed in labelling standards, particularly ISO 15223. This role is critical to ensuring our product labels are compliant, accurate, and aligned with global regulatory requirements. Key Responsibilities: Develop and maintain medical device labels artwork in compliance with applicable regulatory requirements. Ensure labelling content aligns with ISO 15223 (Symbols to be used with medical device labels, labelling and information to be supplied). Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, R&D, and Marketing to gather and validate labelling information. Review labelling changes and provide regulatory input during product development and product updates. Ensure labels comply with regional regulations such as MDR (EU), FDA (US), and other relevant markets. Maintain labelling documentation and change control records in accordance with internal procedures. Monitor updates to labelling standards and regulations and assess their impact existing labelling. Qualifications and Requirements: Bachelor's degree in a scientific, engineering, or healthcare-related discipline. Minimum 2 years of experience in a regulated medical device environment, preferably in labelling or regulatory affairs. Strong knowledge of ISO 15223 and other applicable standards (e.g., ISO 20417, IEC 60601, UDI regulations). Familiarity with regulatory requirements for labelling under EU MDR, US FDA, and other global regulations. Experience with labelling software tools (CorelDraw, Adobe Illustrator or similar tools) and document control systems is a plus. Excellent written and verbal communication skills. High attention to detail and ability to work independently and in teams.
Job Title: Senior Design Engineer Reports to: D&D Head Job Summary: The Senior Design Engineer will lead the design and development of innovative medical devices, ensuring compliance with regulatory and industry standards. This role involves mentoring junior team members, managing complex design projects, coordinating with cross-functional departments, and preparing comprehensive design documentation for regulatory submissions. The candidate must have a strong understanding of manufacturing processes, regulatory expectations, and design control principles. Key Responsibilities: 1. Design & Product Development Lead the design and development of new products and improvements to existing devices using SolidWorks and AutoCAD. Translate clinical and market requirements into functional designs while ensuring manufacturability and cost-effectiveness. Validate engineering calculations, tolerance stack-ups, and material selection for implantable devices and surgical instruments. 2. Project Leadership Plan and execute design activities in alignment with project timelines. Coordinate design reviews, risk analysis, and design verification/validation. Collaborate with the D&D Head to define design strategy and resource allocation. 3. Mentorship & Team Development Guide and mentor Junior Design Engineers in modeling, drafting, design analysis, and documentation. Review work submitted by junior staff and provide constructive feedback. 4. Manufacturing Integration Ensure designs are optimized for manufacturing processes such as CNC machining, laser marking, anodizing, and PEEK/titanium-specific considerations. Work closely with production, quality, and supply chain teams to ensure smooth handover from design to production. 5. Regulatory & Documentation Prepare and review Design History Files (DHF), Technical Files, Risk Management Reports, and Engineering Change Requests (ECRs). Ensure all designs and documentation meet CE MDR, US FDA, and CDSCO regulatory requirements. Support audits and regulatory submissions with accurate and complete documentation. 6. Design Evaluation & Predicate Comparison Conduct design benchmarking and engineering justification reports. Compare new designs against predicate or competitive devices for clinical and functional performance. 7. Innovation & Continuous Improvement Research new design trends, technologies, and surgical techniques in arthroscopy and orthopedics. Contribute to IP development, design patents, and publications where applicable. Qualifications: Education: Bachelors or Master’s degree in Mechanical, Biomedical, or Product Design Engineering. Experience: 3–6 years of experience in medical device design, preferably with exposure to orthopedic/arthroscopic implants and instruments. Skills: Advanced proficiency in SolidWorks and AutoCAD. Strong knowledge of GD&T, DFMA, FMEA, and design verification protocols. Familiarity with regulatory frameworks (CE MDR, US FDA 21 CFR 820, ISO 13485). Hands-on experience with prototype evaluation, testing fixtures, and validation tools. Good communication, leadership, and documentation skills.