General Summary: The Medical Device Test Engineer evaluates endoscopes for compatibility with Wassenburg Medical devices. The Medical Device Test Engineer creates endoscope evaluation and test plans, creates/reviews testing protocols and reports, records and analyzes test data, writes letters to file, and updates applicable device compatibility documentation.

The Medical Device Test Engineer reviews protocols and reports drafted by the Device Testing Technician. The Medical Device Test Engineer collaborates with endoscope manufacturers to obtain endoscopes and pertinent information required for endoscope evaluation and/or validation testing. The Medical Device Test Engineer works collaboratively with the Device Testing Technician and the Director of R&D, as well as Customer Training, QA/RA, Marketing, and other departments to conduct cross functional reviews of endoscope evaluations and/or validation test results. The Medical Device Test Engineer manages the supplies needed for endoscope validation testing. The Medical Device Test Engineer evaluates recalled endoscopes and collaborates with QA/RA to determine the impact and required actions.

Essential Functions:

* Work within an ISO 13485 and FDA compliant Quality Management System * Create and maintain Endoscope Diagrams and Adapter Charts * Update and Maintain Endoscope Qualification Logs * Supervise and train Device Testing Technician(s) * Provide reports periodically to the Director of Research and Development * Coordinate the evaluation/testing of endoscopes with customers and endoscope manufactures * Coordinate the loaning of endoscopes and accessories for testing and evaluation * Manage test endoscope inventory * Coordinate and schedule validation testing with outside laboratories as applicable * Follow approved test protocols, perform (as applicable) device characterization and validation testing activities, document and complete analysis of the testing performed * Use various calibrated tools and instruments utilized for measuring and monitoring (Multimeter, Oscilloscope, Caliper, etc.) * Create and maintain applicable departmental and procedures, work instructions, and forms * Maintain test equipment * Develop, maintain, and organize test data files containing applicable testing and other applicable information * Work as part of or in charge of a cross functional team * Draft test reports for inter-departmental review and approval * Perform other duties as assigned by management

Education Required: Requires a Bachelor's Degree in engineering or related field of study, 1-3 years' experience in a related field preferred

Practical Experience:

* Must be well organized, flexible, and able to work independently with minimum direct supervision performing both routine and complex tasks * Must have strong verbal and written communication skills * Must have strong analytical and problem-solving skills * Punctual, regular, and consistent attendance * Must be technically inclined * Proficient in the use of computers, Word, and Excel * Understanding of computer operating system, file structure, network setup, etc.

Aptitude Required:

* Mental: Constantly * Mechanical: Occasionally * Verbal: Frequently * Personal Initiative: Very Important

Physical Requirements:

* Standing: Occasionally * Walking: Occasionally * Sitting: Constantly * Bending/Stooping/Squatting: Occasionally * Climb Stairs: Rarely * Lying Down: Rarely * Push or Pull: Occasionally * Reach Above Shoulders: Rarely * Climb Ladders: Rarely * Grasp/Grip: Occasionally * Finger Dexterity: Occasionally * Writing/Typing: Constantly * Driving/Operating Equipment: Rarely * Vision (Beyond Arm's Length): Rarely * Lifting/Carrying:

· Over 150 lbs: Rarely · 76 - 150 lbs: Rarely · 51 - 75 lbs: Rarely · 26 - 50 lbs: Rarely · 10 - 25 lbs: Occasionally · 1 - 9 lbs: Occasionally

Environment:

* Hearing Requirements: Frequently * Speaking Requirements: Frequently * Working Indoors: Constantly * Working Outdoors: Rarely * Working in Confined Space: Rarely * Exposure to Fumes, Chemicals, Solvents, Caustics, etc: Occasionally * Extreme Temperatures: Rarely * Eye/Hand/Foot Coordination: Occasionally

Reasoning Development: Apply principles of logical or scientific thinking to define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagrammatic form. Deal with several abstract and concrete variables.

Mathematics: Algebra, Calculus, Statistics Reading: Read manuals, tech journals, and drawings with reasonable comprehension. Writing: Prepare business letters, expositions, summaries, and reports with proper format. Speaking: Speak clearly and distinctly with appropriate pauses and emphasis. Company Description Wassenburg Medical is a world leader in delivering excellent endoscope reprocessing products and solutions. Established in 1984 by Gerrit Wassenburg, the business has developed from a family company into a global player and is expert in all aspects related to automated endoscope reprocessing. Wassenburg Medical has been a member of the HOYA corporation since 2013.

Wassenburg solutions are designed to deliver a safe and controlled treatment of flexible endoscopes. Our end-to-end total solution includes pre-cleaning, washing and disinfection, storage, transport and traceability.

Since its establishment, Wassenburg has grown exponentially. With headquarters in the Netherlands, sales offices in the UK, Ireland, Belgium, France, Germany, United States and an exclusive distributors network in Europe, Middle East, Australia, New Zealand and Africa. Wassenburg Medical is expanding its global footprint rapidly.

Company Description

Wassenburg Medical is a world leader in delivering excellent endoscope reprocessing products and solutions. Established in 1984 by Gerrit Wassenburg, the business has developed from a family company into a global player and is expert in all aspects related to automated endoscope reprocessing. Wassenburg Medical has been a member of the HOYA corporation since 2013.\n\nWassenburg solutions are designed to deliver a safe and controlled treatment of flexible endoscopes. Our end-to-end total solution includes pre-cleaning, washing and disinfection, storage, transport and traceability.\n\nSince its establishment, Wassenburg has grown exponentially. With headquarters in the Netherlands, sales offices in the UK, Ireland, Belgium, France, Germany, United States and an exclusive distributors network in Europe, Middle East, Australia, New Zealand and Africa. Wassenburg Medical is expanding its global footprint rapidly.