Develop Test methods to verify the design of new products are safe, effective and meet the requirements set forth by the functional specifications for the device
Coordination of testing new products/components/designs and/or design changes to existing products. Accountable for the testing delegated to them from experimentation to design verification.
Experience on performing Cantilever, Bending and Shear Fatigue Testing on metals per standards
Write test protocols that document and qualify verification test methods.
Execute test methods and protocols in the evaluation of medical devices, components and materials.
Performs statistical data analysis to identify areas of variability, determine sample size, and otherwise analyze test data.
Writes test reports that document test results and draws conclusions from test data.
Able to work with vendors to design and fabricate custom test fixtures as necessary
Understanding of design controls, quality system regulations, and CAPA process
Technical / Soft Skills
Candidates should have a Bachelor's degree (Master's degree is preferred) in Engineering or Science such as Materials Science, Materials (Metallurgy) Engineering, Mechanical Engineering, or Biomedical Engineering.
Experience in a Medical Device and/or regulated work environment is required.
Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
Statistical techniques and methods.
A strong communication and interpersonal skills is required.
Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Marketing).
Excellent decision-making and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.