Mechanical Engineer

3 weeks ago

Mysuru, 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.

 

Responsibilities

  • Collaborate 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.


Qualifications

  • Bachelor'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 budget
  • Proficiency 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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