Mechanical Engineer

3 weeks ago

Mysore, India AeroDel Technology Innovations Pvt Ltd Full time
We are seeking a highly skilled Mechanical Engineer with experience in the medical domain to join our team. The ideal candidate will have a strong background in product design, design for manufacturing, finite element analysis (FEA), and a solid understanding of ISO 13485 quality management systems. The successful candidate will play a crucial role in the development of innovative respiratory medical devices, ensuring compliance with regulatory standards and optimising product performance.

ResponsibilitiesCollaborate with cross-functional teams to conceptualise, design, and develop respiratory medical devices from initial concept through production.Conduct feasibility studies and risk assessments to inform the design process and ensure compliance with regulatory requirements.Utilize CAD software to create detailed 3D models and engineering drawings for components and assemblies.Perform finite element analysis (FEA) to evaluate structural integrity, thermal performance, and fluid dynamics of medical device designs.Apply design for manufacturing (DFM) principles to optimize product manufacturability, cost-effectiveness, and scalability.Work closely with suppliers and manufacturing partners to prototype, test, and iterate designs for performance optimization and manufacturability.Support the development and maintenance of design control documentation, including design inputs, verification/validation protocols, and risk management files, in accordance with ISO 13485 and other relevant standards.Participate in design reviews, risk management meetings, and regulatory submissions to ensure compliance with applicable standards and regulations.Stay current with industry trends, best practices, and emerging technologies in medical device design and regulatory compliance.

QualificationsBachelor's degree in Mechanical Engineering or related field; evaluation will be based on skill set.3-5 years of experience in mechanical design and product development within the medical device industry, preferably in the Class 2 Medical devices.Excellent problem-solving skills and attention to detail.Effective communication and collaboration skills, with the ability to work in cross-functional teams.Proven track record of delivering high-quality, innovative medical device designs on time and within budgetProficiency in CAD software (e.g., SolidWorks, Fusion 360) for 3D modeling and engineering drawings.Strong understanding of finite element analysis (FEA) techniques and software (e.g., ANSYS, Abaqus).Experience with design for manufacturing (DFM) principles and practices.Familiarity with ISO 13485 quality management system requirements and medical device regulations (e.g., FDA QSR, EU MDR).

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