Design Assurance Engineer-Medical Devices
2 weeks ago
Design Assurance Engineer
Responsibilities:
- Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory requirements.
- Working with the verification and validation efforts to ensure that the product meets design specifications and user requirements.
- Working with documentation related to design inputs, outputs, reviews, and changes to ensure traceability and compliance with regulatory requirements.
- Working closely with cross-functional teams including R&D, manufacturing, quality assurance, and regulatory affairs to ensure alignment and collaboration throughout the design process.
Qualifications:
- Demonstrated track record with 21 CFR 820, ISO 13485, or equivalent quality regulations.
- Organize system level DHF's (Design History Files)
- Help setup IVD (In Vitro Diagnostic) medical device design process.
- Proficient with the generation and execution of qualifications, validation protocols, and quality assurance procedures
- Knowledge of Class 1 medical devices preferred.
- A minimum of 5+ years of working experience in regulated manufacturing (e.g., IVD, Medical Device, Automotive, etc.) is required.
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