Systems Test Engineer I - PCIG Systems

The Systems Test Engineer is a Design Quality Engineer that directly supports medical device product development from concept through commercialization. The engineer will work within a cross-functional team to develop and validate test methods, support design verification activities, and generate objective evidence of product performance. This position focuses on laboratory-based testing, data analysis, and design of test methods and equipment to satisfy product requirements., *Develop test methods and test equipment to evaluate product performance and satisfy design verification requirements. *Support the development and execution of test method validation activities. *Plan and execute design verification testing to support product development programs. *Analyze test data and communicate technical conclusions through reports and presentations. *Write technical documentation including protocols, reports, and procedures. *Apply systematic problem-solving methodologies to identify, investigate, and resolve technical issues. *Support prototype and commercial product testing in a laboratory environment. *Collaborate effectively within cross-functional teams including R&D, Design Assurance, Project Management and Regulatory. *Support laboratory activities including development of test fixtures, equipment, and experimental setups. *Demonstrate initiative, independent thinking, and ownership of assigned projects. *Understanding human anatomy and physiology and be able to apply that knowledge to the usage of medical devices.

Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

*Bachelor’’s degree in mechanical engineering, Biomedical Engineering, Computer and Electrical Engineering or related engineering discipline. *1-2 years of engineering, laboratory, internship, co-op, or research experience. *Hands-on approach to product development and laboratory testing. *Self-motivated with a passion for solving problems and a bias for action. *Strong communication skills (verbal and written). *Strong technical and analytical problem-solving skills. *Ability to work independently while contributing to a team environment. *Travel as required (<10%).

Preferred qualifications: *ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis *Experience supporting design verification testing. *Previous experience with Measurements System Analysis *Experience integrating data acquisition equipment and clinically relevant simulated environments *Previous medical device, product development, or research experience. *Experience using SolidWorks 3D Modeling Software or equivalent *Experience using Minitab statistical software *Experience using LabVIEW, MATLAB, and Python programming languages *Experience using a variety of laboratory equipment including oscilloscopes, signal generators, and a variety of data acquisition equipment and sensors