About the role:
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.
Your responsibilities include:
"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.
Minimum qualifications:
"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