## Job Summary Experience in the medical device industry, specializing in Product Lifecycle Management (PLM) and Product Data Management (PDM), preferably using Windchill. The candidate should be proficient in SolidWorks (Parts, Assemblies, and Drawings) and have hands-on experience in Verification and Validation (V&V) activities. Responsibilities include creating and maintaining process instructions, work documentation, and supporting engineering change and product development activities. The ideal candidate will possess strong verbal and written communication skills and be able to collaborate effectively with cross-functional teams while ensuring compliance with quality and regulatory requirements. ## Key Responsibilities - Manage and maintain product data, documentation, and engineering records within PLM/PDM systems, preferably Windchill. - Create, modify, and release SolidWorks Parts, Assemblies, and Drawings in accordance with company standards and procedures. - Support product development activities, including design changes, document updates, and engineering change processes. - Execute and document Verification & Validation (V&V) activities to ensure product compliance with design and regulatory requirements. - Develop, review, and maintain Process Instructions, Work Instructions, SOPs, and technical documentation. - Ensure compliance with medical device quality standards, regulatory requirements, and internal procedures. - Coordinate with cross-functional teams including Design, Quality, Manufacturing, and Regulatory Affairs to support project objectives. - Perform design reviews and documentation reviews to ensure accuracy, completeness, and traceability. - Support risk management, product lifecycle activities, and continuous process improvement initiatives. - Communicate project status, technical issues, and recommendations effectively with internal and external stakeholders. . ## Skill Requirements Experience in the Medical Device industry.Strong knowledge of Product Lifecycle Management (PLM) and Product Data Management (PDM) systems, preferably Windchill.Proficiency in SolidWorks including Parts, Assemblies, and Drawings modules.Hands-on experience in Verification & Validation (V&V) activities and documentation.Experience in creating, reviewing, and maintaining Process Instructions, Work Instructions, SOPs, and technical documentation.Knowledge of engineering change management processes (ECR, ECO, ECN, CR/CN).Understanding of medical device quality systems and regulatory requirements.Strong analytical, problem-solving, and troubleshooting skills.Ability to work effectively in cross-functional and global team environments.Experience with document control, configuration management, and design documentation.Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).Excellent communication skills, including professional reading, writing, and speaking abilities.Ability to manage multiple tasks, prioritize work, and meet project deadlines ## Other Requirements