Mechanical Engineer

9 hours ago


New Haven, Connecticut, United States Futran Tech Solutions Pvt. Ltd. Full time
Job Title: Mechanical Engineer

Futran Tech Solutions Pvt. Ltd. is seeking a highly skilled Mechanical Engineer to join our team. As a Mechanical Engineer, you will be responsible for designing, developing, and testing mechanical systems and components.

Key Responsibilities:
  • Design and develop mechanical systems and components
  • Conduct process validation and ensure compliance with ISO 13485
  • Lead cross-functional teams and implement process improvements
  • Develop and maintain SPC and statistical process control systems
  • Ensure regulatory compliance with FDA and 21 CFR 820
  • Collaborate with project managers to develop and implement project plans
  • Develop and maintain Minitab and other analytical tools
  • Identify and solve complex problems through process engineering and problem-solving skills
Requirements:
  • Bachelor's degree in Mechanical Engineering or related field
  • Minimum 5 years of experience in mechanical engineering and process validation
  • Strong knowledge of ISO 13485 and FDA regulations
  • Excellent leadership and communication skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks

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