Job Description

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates with the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES :

• Execute product testing to support R&D Engineering

1. Design development
2. Manufacturing development
3. Design verification
4. Process validation

• Develop test methods for product evaluation and validation.
• Develop and execute test method validations.
• Develop and execute required validations in line with regulatory requirements to include Equipment, Process and Product validations.
• Address design and tolerance issues as they arise.
• Design and development of test fixtures and simulated use models.
• Analysis and reporting of results including statistics and image analysis Authorship of test methods, protocols & reports.
• Coordination with Manufacturing, Operations, and external suppliers as needed.
• Other duties as assigned.

EXPERIENCE/SKILL REQUIREMENTS:

1. 1-3 years’ experience in industry under a quality system (ISO 9000/9001, ISO 13485, etc.)
2. Experience in laboratory work and hands-on testing
3. Analytical approach to problem solving.
4. Adept at managing multiple tasks, prioritizing, and working with others.
5. Proficient in CAD design
6. Ability to analyze, understand and effectively communicate technical information.
7. Working knowledge of basic statistics
8. Experience in medical devices a plus

EDUCATIONAL REQUIREMENTS:

B.S. or B.E. in the field of Mechanical Engineering, Biomedical Engineering, Physics

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