Senior Mechanical Design Engineer - Medical Devices

Senior Design Engineer Work Flexibility: Hybrid Role and Responsibilities: Lead the design and development of mechanical components and systems for medical devices, executing end-to-end new product development (NPD) across all product lifecycle phases—from concept generation and detailed design through verification, validation, and product launch. Own engineering change management activities, including impact assessments, documentation, approvals, and implementation, while coordinating with cross-functional stakeholders to ensure timely execution. Translate user, clinical, and business needs into engineering requirements, product specifications, and system-level designs. Perform engineering analyses, including simulations, engineering calculations, tolerance analysis, and statistical evaluations, to optimize product performance, quality, and reliability. Prepare and maintain comprehensive engineering documentation, including Design History Files (DHF), Device Master Records (DMR), engineering drawings, Bills of Materials (BOMs), labelling, Instructions for Use (IFUs), engineering specifications, and design records, ensuring compliance with company standards, regulatory requirements, and quality system procedures. Prepare and maintain detailed 3D models, engineering drawings, schematics, and specifications using CAD software, preferably Creo Parametric , while applying GD&T in accordance with industry standards. Collaborate with laboratory teams to plan and execute verification and validation (V&V) activities, including test method development, protocol preparation, test execution, data analysis, and technical reporting. Partner effectively with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, Clinical, Marketing, Supply Chain, and Operations to deliver projects within scope, quality, cost, and schedule. Support prototype development, design verification, design validation, manufacturing transfer, product launches, value engineering, cost reduction initiatives, and continuous product improvements. Apply Design for Manufacturing and Assembly (DFM/DFA) principles, materials selection, and manufacturing process knowledge to develop robust, manufacturable, and cost-effective designs. Lead or contribute to technical design reviews and collaborate with global stakeholders, suppliers, vendors, and subject matter experts (SMEs) to resolve technical challenges and drive project success. Ensure compliance with applicable quality and regulatory requirements, including Design Controls, Risk Management, and company engineering processes throughout the product development lifecycle. Required Skills Bachelor’s degree in mechanical engineering; 4+ years of experience in mechanical design and product development. Experience- 5 years- 7 years; Expertise in Creo Parametric with hands-on experience in 3D modelling, drafting, engineering drawings, and application of GD&T; experience designing mechanical components, including machined, sheet metal, molded, or cast parts. Knowledge of Design for Manufacturing and Assembly (DFM/DFA), materials selection, manufacturing processes, engineering calculations, tolerance analysis, and thermal analysis/simulation. Understanding of engineering change management processes. Preferred Qualifications Experience with Product Lifecycle Management (PLM/PDM) systems, preferably Windchill . Working knowledge of verification and validation methodologies, root cause analysis, DFMEA/PFMEA, and statistical analysis tools. Exposure to regulated product development in industries such as medical devices, consumer electronics, industrial equipment, automotive, or aerospace. Travel Percentage: None Experience Level Senior Level