Test Engineering Manager - Gentuity, LLC : Job Details

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 is 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:

Five plus 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