Medical Device Engineer

1 month ago

Buffalo, United States CivicMinds, Inc Full time

Job: Sr. Medical Device Engineer

Location: Buffalo, NY (Direct Hire)


Job Summary: Plans, designs, and develops production processes for single-use medical devices, ensuring compliance with customer specifications and company procedures.

Job Duties:

  • Leads customer projects, managing schedules and resources for successful project execution.
  • Coordinates development activities internally and with customers to meet deadlines.
  • Translates customer needs into engineering specifications and manufacturing processes.
  • Ensures regulatory compliance with FDA, ISO, and other standards.
  • Identifies materials, designs tooling, and optimizes production for volume, cost, and quality.
  • Prepares engineering documents and oversees product testing/validation.
  • Designs and validates manufacturing tooling, equipment, and processes.
  • Maintains engineering documents and stays updated on industry trends and technologies.
  • Assists sales in estimating materials and labor for quotations.
  • Mentors new Product Engineers.
  • Demonstrates company values of honesty, integrity, and respect.
  • Performs other duties as assigned.

Skills/Technical Skills:

  • Strong communication and teamwork skills.
  • Proficiency in Microsoft Office, Solidworks, and related software.
  • Experience with Lean Manufacturing/6 Sigma methodologies.
  • Knowledge of injection molding, ultrasonic welding, or radio frequency welding.

Knowledge:

  • Familiarity with regulatory environments (FDA, FAA, ISO 13485).
  • Preferred knowledge of medical device manufacturing and world-class manufacturing.

Experience:

  • 4+ years of related experience.
  • Experience in regulated environments.
  • Familiarity with production line layout and process validations.

Education:

  • Bachelor’s degree in Mechanical, Plastics, Biomechanics, or Biomedical Engineering.

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