R&D Chemist

Description

Position Summary: Design, execute, and document development testing for new medical devices, ensuring traceability and regulatory compliance. Key Highlights: 1. Development of innovative medical devices 2. Quality management and regulatory compliance 3. Multidisciplinary collaboration and decision-making **Position: Development Chemist** **Position Objective** Design, execute, and document development testing for new medical devices and related supplies, ensuring generated results support technical and regulatory decisions under a Right\-First\-Time approach. Ensure design traceability, regulatory requirement compliance, and validated product transfer to manufacturing, directly contributing to DL Médica’s competitiveness and expansion of its innovative portfolio. **Key Responsibilities:** · Design and Execution of Development Testing · Plan pilot studies, functional testing, and physicochemical characterization of materials. · Coordinate laboratory and plant-based testing activities with multidisciplinary teams. · Establish technical criteria for manufacturing scale-up and supplier selection. · Documentation in Quality Management System · Prepare protocols, technical reports, and QMS records per ISO 13485\. · Ensure design traceability via DHF, risk matrices, verifications, and validations. · Document technical changes and decisions with supported evidence and version control. · Risk Management and Preventive Compliance · Participate in risk identification and mitigation (ISO 14971 / FMEA). · Integrate regulatory requirements early in development (compliance by design). · Support generation of data packages for audits, COFEPRIS, and FDA. **Position Profile:** · Academic Qualifications · Bachelor’s degree in Chemistry, Biotechnology, Chemical Engineering, Biomedical Engineering, or related field. · Preferred: Specialization or Master’s degree in Materials Science and Engineering or Pharmaceutical/Medical Device Technology. **Experience:** · 2–4 years in R&D laboratories or quality assurance within medical devices, pharmaceuticals, or biomedical materials. · Proficiency in analytical instrumentation and product functional testing. · Experience participating in design or process verifications and validations. · Technical Knowledge · Applicable medical device regulations: ISO 13485, ISO 14971, ISO/ASTM. · Polymeric materials, medical-grade steels, and biocompatibility principles. · Sampling methodologies and statistical analysis of results. · Technical English for document interpretation. **Competencies:** · Scientific critical thinking and data-driven decision-making. · Effective communication and cross-functional coordination. · High level of organizational and documentation discipline. · Creativity applied to solving complex technical problems. · Performance Indicators (KPIs) Employment Type: Full-time Salary: Starting at $20,000\.00 per month Benefits: * Grocery vouchers Work Location: On-site employment