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Mechanical Design Engineer

2 months ago

Navi Mumbai, India IF MedTech Pvt Ltd Full time

Job Summary:

The Mechanical Design Engineer will play a critical role in the development and design of innovative medical devices, ensuring compliance with ISO 13485 and other regulatory standards. The candidate will collaborate with cross-functional teams to deliver high-quality, reliable products that meet industry and customer expectations. This role demands strong technical expertise in mechanical engineering, excellent problem-solving skills, and a dedication to continuous improvement and innovation in medical device development.


Responsibilities:

  • Collaborate with cross-functional teams to define project requirements, including product specifications, performance criteria, and regulatory compliance standards.
  • Assist in the preparation of project proposals and scope of work for new projects.
  • Develop and execute mechanical design efforts for medical devices, including concept generation, detailed design, prototyping, testing, and Design for Manufacturing and Assembly (DFMA).
  • Conduct feasibility assessments and assist in technology identification and product architecture design.
  • Perform risk assessments and participate in risk management activities to identify, assess, and mitigate technical and project risks.
  • Create and review engineering drawings, ensuring compliance with standards and manufacturability.
  • Coordinate prototype builds and testing activities, analyze test data, and iterate designs to achieve desired performance objectives.
  • Support the development and verification of technical documentation, including design specifications, test protocols, reports, and regulatory submissions.
  • Source materials, components, and fabrication processes in collaboration with suppliers and manufacturing vendors.
  • Participate in internal design reviews to ensure performance and reliability of medical device designs.
  • Stay current with industry trends, emerging technologies, and regulatory requirements related to medical device development.
  • Assist in the selection of critical components and decision-making processes.
  • Ensure all design documents are updated and in line with requirements.


Requirements


Required Skills:

  • Strong understanding of engineering principles, materials, and manufacturing processes relevant to medical device development.
  • Proficiency in Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Reliability (DFR) principles.
  • Familiarity with regulatory requirements and standards applicable to medical devices, such as ISO 13485.
  • Excellent project management skills, including task prioritization, timeline management, and effective communication with stakeholders.
  • Demonstrated problem-solving abilities and a proactive approach to technical challenges.
  • Strong interpersonal skills and the ability to work effectively in a collaborative, multidisciplinary team environment.
  • Commitment to quality, safety, and compliance in all aspects of work.


Educational Qualifications:

  • Bachelor’s or Master’s degree in Mechanical Engineering or a related field. A Master’s degree is preferred.
  • Minimum of 2 years of experience in mechanical design and development, preferably in the medical device industry.