Test Engineer II (ITEngineering)

We are seeking a Test Engineer II to support the development of disposable medical device products. This role involves designing developing and executing test strategies that align with technical schedule and cost constraints within an R&D environment. The ideal candidate will have hands-on engineering experience strong problem-solving skills and familiarity with medical device testing and regulatory standards.

• Design develop and execute comprehensive test plans protocols and procedures to validate product designs against specifications.
• Translate design requirements into effective testing solutions considering technical and operational constraints.
• Review and evaluate test requirements to ensure completeness and accuracy of test programs.
• Coordinate integrated testing activities including resource planning (labor equipment and space).
• Analyze test data document results and recommend improvements to test methods equipment or processes.
• Support prototyping testing of developmental assemblies and test fixture design.
• Develop and validate test methods incorporating statistical analysis and experimental design principles.
• Maintain R&D lab organization calibration records and perform preventive maintenance of equipment.
• Identify procure calibrate and utilize lab equipment effectively.
• Communicate technical findings through reports presentations and status updates.
• Collaborate with cross-functional teams including product development suppliers and quality teams.
• Ensure compliance with applicable standards including FDA Quality System Regulations CE marking and ISO standards.
• Participate in risk identification and escalate issues appropriately to ensure timely resolution.

• Bachelor s degree in Engineering or a related technical field.
• Minimum 2 years of hands-on engineering experience.
• Proficiency in SolidWorks or similar CAD tools.
• Strong execution skills with a hands-on approach to testing and problem-solving.

• Degree in Mechanical Biomedical or Materials Engineering.
• Experience with statistical analysis and experimental design.
• Familiarity with machining or working in a machine shop environment.
• Experience in medical device development under regulated environments.

• Strong troubleshooting and analytical problem-solving skills.
• Proficiency with lab equipment such as microscopes tensile testers noise & vibration analyzers and related tools.
• Familiarity with tools such as Microsoft Word Excel PowerPoint and Minitab.
• Knowledge of CAD tools such as SolidWorks eDrawings or AutoCAD.
• Effective written and verbal communication skills.
• Ability to work collaboratively in a team-oriented environment.