Provide overall direction for QMS activity within Engineering function
Ensure uninterrupted engineering services for Production
Design and develop mechanical components and systems for medical devices, equipment, and instrumentation.
Collaborate with interdisciplinary teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to achieve project goals.
Perform engineering calculations, simulations, and testing to validate designs and ensure compliance with industry standards and regulatory requirements.
Participate in design reviews, risk assessments, and technical documentation activities.
Stay updated on emerging technologies, trends, and best practices in mechanical engineering and medical device industry.
Ensure efficient generation and distribution of Utilities such as Electricity, Water, Steam, Water, Compressed Air, Chilled water, Hot water, Cooling water, etc.
Ensure preparation of effective preventative and predictive maintenance programme and ensuring that it is carried out in totality.
Carry out weekly maintenance of equipment as per preventive maintenance plan.
Ensure minimum equipment breakdown for smooth production operations.
Daily, Weekly, Monthly report preparation and submission.
Ensure prompt attendance to alert from all departments and also CAPA implementation for same.
Cost control by root cause analysis of Breakdowns to prevent reoccurrence.
Discipline in the Engineering function.
Training to Staff as per plan and reviewing the same
Minimum of 12 years of experience in mechanical engineering, with a focus on product design and development.
Previous experience in the medical device industry is highly desirable.
Bachelor's degree in Mechanical Engineering or related field (Master's degree preferred).
Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for 3D modeling and drafting.
Strong understanding of mechanical design principles, materials, and manufacturing processes.
Experience with design analysis tools (e.g., Finite Element Analysis, Computational Fluid Dynamics).
Knowledge of regulatory requirements and standards applicable to medical devices (e.g., ISO 13485, FDA regulations).
Excellent problem-solving and analytical skills.
Effective communication and collaboration abilities.
Attention to detail and accuracy.
Ability to manage multiple projects and prioritize tasks effectively.
Commitment to continuous learning and professional development.
Minimum of 12 years of experience in mechanical engineering, with a focus on product design and development.
Previous experience in the medical device industry is highly desirable.
Bachelor's degree in Mechanical Engineering or related field (Master's degree preferred
