REQUIRED QUALIFICATIONS

• A bachelor’s degree in engineering is required.
• 3-5 years’ experience designing test stations using LabView development tools.
• Experience with the development and performance of verification and validation testing required for high reliability critical care devices.
• Excellent verbal and written communication skills, with strong technical writing abilities.
• Excellent interpersonal, organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Proficient in Microsoft Suite
• Knowledge of C#.

PREFERRED QUALIFICATIONS

• Experience in a medical or highly regulated environment is desired but not required.
• Knowledge of FDA electronic design documentation and test requirements for 510K submissions.

PHYSICAL REQUIREMENTS

Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs

JOB PURPOSE

The Test Engineer assumes responsibility for the verification and validation of new and existing products and components. The Test Engineer will be responsible for the development and maintenance of automated test stations for both R&D and Manufacturing.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Design, develop and maintain automated test equipment to enhance production productivity and V&V by utilizing electronic-mechanical hardware and LabVIEW software.
• Lead V&V activities including collaboration with cross functional team members, early risk retirement, time management, and generation of technical documents such as test plan, protocols and reports.
• Create and release technical documents such as design specifications, technical drawings, test protocols, and reports.
• Follow good design practices in accordance with FDA design control guidelines and the company’s design control process and procedures.
• Improve test processes in engineering and manufacturing.
• Troubleshoot system level problems, analyze and solve root causes in engineering and manufacturing.
• Collaborate with cross functional team members to propose and implement solutions and design improvements.
• Adheres to all company policies, procedures and business ethics codes.
• Perform other duties as assigned.