Medical Device Design and Development Specialist

6 days ago


Mountain View, California, United States Gateway Recruiting Full time
Job Summary

Gateway Recruiting is seeking a highly skilled Medical Device Engineer II to join our team. As a key member of our development team, you will be responsible for establishing and maintaining design history file documentation, risk management documentation, and coordinating product testing with vendors.

Key Responsibilities:
  • Develop and maintain design history file documentation, including design and development plans, requirements specifications, and verification and validation summary reports.
  • Establish and maintain risk management documentation, including risk management plans and hazards analyses, in accordance with ISO 14971.
  • Coordinate product testing with vendors, including protocol development, sample coordination, and writing test reports.
  • Review deliverables from vendors, such as technical drawings and technical reports.
  • Generate technical protocols and reports.
  • Develop validation master plans, IQ/OQ/PQ protocols, and reports for test fixtures and manufacturing equipment.
  • Review mechanical drawings and electrical schematics.
Requirements:
  • Excellent technical writing skills.
  • Excellent mechanical aptitude and good attention to detail.
  • Excellent oral and written communication skills, as well as strong interpersonal skills.
  • Well-versed in FDA regulations for medical devices and products, including Design Controls 21 CFR 820 and MDR.
  • Experience working in compliance with GMP regulations.
  • Experience with mechanical drawings and electrical schematics preferred.
Education and Experience:
  • Bachelor's or higher-level STEAM degree, Physics, or related field, or demonstrated equivalent experience.
  • 2+ years of product development experience in medical devices.
Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.


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