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
οΏ½ Design, develop and maintain automated test equipment to enhance production productivity and V&V by utilizing electronic-mechanical hardware and LabVIEW software.
οΏ½ 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.
οΏ½ Create and release technical documents such as design specifications, technical drawings, test protocols, and reports.
οΏ½ Follow good design practices in accordance with FDA design control guidelines and the companyοΏ½s design control process and procedures.
οΏ½ Improve test processes in engineering and manufacturing.
οΏ½ Troubleshoot system level problems, analyze and solve root causes in engineering and manufacturing.
οΏ½ Collaborate with cross functional team members to propose and implement solutions and design improvements.
οΏ½ Adheres to all company policies, procedures and business ethics codes.
οΏ½ Perform other duties as assigned.
Required Qualifications
οΏ½ A bachelor's degree in engineering is required.
οΏ½ 3-5 yearsοΏ½ experience designing test stations using LabView development tools.
οΏ½ Experience with the development and performance of verification and validation testing required for high reliability critical care devices.
οΏ½ Excellent verbal and written communication skills, with strong technical writing abilities.
οΏ½ Excellent interpersonal, organizational skills and attention to detail.
οΏ½ Strong analytical and problem-solving skills.
οΏ½ Proficient in Microsoft Suite
οΏ½ Knowledge of C#.
Preferred Qualifications
οΏ½ Experience in a medical or highly regulated environment is desired but not required.
οΏ½ Knowledge of FDA electronic design documentation and test requirements for 510K submissions.
Compensation
The anticipated range for this position is $83,300.00 to $109,200.00 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.
Working Conditions
οΏ½ Works in an office environment which includes laboratory and manufacturing areas.
οΏ½ Works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.
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.