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Mechanical Design Engineer

2 months ago

St Louis, Missouri, United States Intellectt Inc Full time
Job Title: Mechanical Design Engineer

At Intellectt Inc, we are seeking a highly skilled Mechanical Design Engineer to join our team. As a key member of our product development team, you will be responsible for designing and developing mechanical components and systems for medical devices.

Key Responsibilities:

  • Design and develop mechanical components and systems for medical devices, ensuring compliance with regulatory and quality standards.
  • Create detailed 3D CAD models and engineering drawings using SolidWorks or equivalent software.
  • Perform tolerance stack-up analysis, FMEA, and root cause analysis for design improvements and troubleshooting.
  • Collaborate with R&D, manufacturing, and quality teams to optimize designs for cost, functionality, and manufacturability.
  • Conduct prototyping, testing, and validation of mechanical systems, ensuring performance and reliability.
  • Generate and maintain design documentation, including specifications, design history files, and validation reports.
  • Work with suppliers to ensure that components meet design requirements and are delivered on time.
  • Ensure designs comply with industry standards (ISO, FDA) and internal quality processes.
  • Participate in design reviews and present technical details to internal teams and stakeholders.
  • Support continuous improvement initiatives, contributing to process optimization and innovation.

Requirements:

  • Bachelor's degree in Mechanical Engineering or a related field.
  • 5+ years of experience in mechanical design, preferably in the medical device industry.
  • Proficiency in CAD software (SolidWorks, AutoCAD, or similar).
  • Strong knowledge of materials, manufacturing processes, and mechanical systems design.
  • Familiarity with regulatory requirements for medical devices (ISO 13485, FDA CFR Part 820).
  • Excellent problem-solving skills and ability to work in a fast-paced environment.
  • Strong communication and teamwork skills to work with cross-functional teams.
  • Experience with validation and verification processes is preferred.