Engineering Manager at Pause Factory

Job Summary:

The Mechanical Engineer plays a key role in the design, development, and maintenance of mechanical systems and components for medical devices and equipment. Working closely with cross-functional teams, the Mechanical Engineer contributes to the innovation and improvement of products, ensuring they meet quality, safety, and regulatory standards.

Responsibilities:

• 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

Job Specification:

• 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.

Benefit;

• Competitive Salary
• HMO
• Pension
• Professional body yearly allowance.
• Performance Bonus.
• Leave Allowance
• 13th month.