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Medical Device Engineer II
2 months ago
We are seeking a highly skilled Medical Device Engineer II to join our team at Gateway Recruiting. As a key member of our product 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, and develop validation master plans, IQ/OQ/PQ protocols, and reports for test fixtures and manufacturing equipment.
- Review mechanical drawings and electrical schematics.
- Excellent technical writing skills and mechanical aptitude.
- Strong oral and written communication skills, as well as excellent 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.
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 RequirementsProlonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Must be willing to travel.
