Test Engineering Manager
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 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:
• Manage product design verification and validation activity including disposables, hardware, software and external testing in line with product specifications and regulatory requirements.
• Develop test methods for product evaluation and validation.
• Ensure the Test Engineering Team is equipped with the necessary resources and equipment to support design verification and validation activities across the company.
• Liaise with project leads to understand testing requirements associated with new product design.
• Interface with R&D, Manufacturing, Clinical, Quality, Regulatory, Marketing and Operations to ensure that the transition of products through testing are smooth, timely and cost effective.
• As part of the R&D team, contribute effectively to the broader technical and resource needs of the team while ensuring specific technical expertise is continually developed and strengthened.
• Participate in research activities in partnership with Gentuity leading collaborators, including in vivo testing of medical products and data analysis.
• Develop tools for the automated analysis of biomedical image and mechanical data.
• Build and maintain databases of Gentuity test data.
Other duties as assigned.
EXPERIENCE/SKILL REQUIREMENTS:
Up to 5 years of experience in medical devices.
• An analytical approach to problem solving
• Adept at managing multiple tasks, prioritize and work for a team
• Ability to analyze, understand and effectively communicate technical information
• Excellent written and verbal communication skills.
• Working knowledge of basic statistical analyses
• Experience with scripting software languages a plus
EDUCATIONAL REQUIREMENTS:
• A BS or MS in Mechanical or Biomedical Engineering or equivalent job experience