Key Responsibilities:
Design and develop current medical devices or plastic components using CREO / SolidWorks.
Prepare and review engineering drawings, 3D models, and BOMs as per design standards.
Manage and implement Engineering Change Requests/Notices (ECR/ECO/ECN) for design updates.
Support design verification and validation activities, including DFMEA, risk assessment, and testing documentation.
Prepare design history files (DHF), technical documentation, and ensure compliance with CE/FDA design control requirements.
Participate in prototype development, testing, and design reviews.
Ensure all product designs meet quality, safety, and regulatory standards.
Continuously improve design processes and support cost reduction/efficiency projects.
Required Skills & Competencies:
Proficient in CREO or SolidWorks (mandatory).
Sound understanding of product design, GD&T;, DFM, DFA, and tolerance analysis.
Experience in ECR/ECN processes.
Knowledge of medical device design and relevant regulatory requirements (ISO 13485, CE, FDA) preferred.
Solid problem-solving, analytical, and documentation skills.
Valuable communication and teamwork abilities.
📌 R&d Engineer Faridabad (India)
🏢 Polymed
📍 India