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Mechanical Engineer

2 months ago

Asheville, North Carolina, United States Saxon Global Full time
Job Description

Job Title: Mechanical Engineer - Medical Device Industry

Job Summary:

Saxon Global is seeking a highly skilled Mechanical Engineer to join our team in the medical device industry. As a Mechanical Engineer, you will be responsible for designing, developing, and testing medical devices to ensure they meet the highest standards of quality and safety.

Key Responsibilities:

  • Design and Development: Design and develop medical devices, including prototypes, to meet the needs of our clients.
  • Project Execution: Coordinate with cross-functional teams to ensure successful project execution, including daily syncs with offshore teams and leadership.
  • Product Verification: Perform product verification to evaluate the overall performance, reliability, and safety of medical devices.
  • Cost Out Opportunities: Identify cost out opportunities that are quality neutral and perform cost benefit analysis to finalize annualized savings.
  • Regulatory Affairs: Work with Regulatory Affairs team members to acquire required product approvals, such as U.L., FDA, C.S.A., and European product certifications.

Requirements:

  • Education: Bachelor's or Master's degree in Mechanical Engineering.
  • Experience: Proven working experience in mechanical engineering, specifically in the design and development of medical devices.
  • Skills: Solid understanding of core concepts, including mechanics, kinematics, thermodynamics, and materials science. Strong communication skills to work globally and across functions.

Preferred Qualifications:

  • Design Verification Plan Development: Ability to develop and implement design verification plans.
  • Project Management: Knowledge of project management principles and practices, including scope, schedule, cost, and quality management.
  • Safety Regulatory Requirements: Knowledge of safety regulatory requirements for medical devices.