Medical Device Design and Development Specialist
6 days ago
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.
- 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.
- Bachelor's or higher-level STEAM degree, Physics, or related field, or demonstrated equivalent experience.
- 2+ years of product development experience in medical devices.
- 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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