Develops high level verification and validation test plans for instrument, accessories, endoluminal, or vision projects
Generates and takes ownership of test protocols for Design Verification and Life/Reliability tests
Collaborate with Design and Clinical teams to develop test methods needed to ensure design requirements are sufficiently verified
Executes test protocols for clinically-based surgical simulation and automated testingutilizingda Vinci surgical system, IonSystemsand/or other test equipment
Identifies and presents problems that arise during feasibility and design verification testing, and escalates new or persistent failure modes toappropriate engineeringteams
Collaborates withappropriate engineeringteams on the failure investigation and root cause analysis.
Clearly documents test results and observations in test report
Test Fixture Development
Designs test fixtures and other test aids needed to perform Design Verification and Life/Reliability tests
Identifies processes and test methods that could benefit from new or updated fixture designs
Works with other engineers to develop concepts and approaches to fixture design
Responsible for documentation of fixtures utilizing SolidWorks; release of documents into Agile
Other Responsibilities
Effectively translate the functional requirements intoappropriate acceptancecriteria for testcases and test methods.
Train test technicians on test methods and procedures
Ensures successful, on-time completion of department projects; communicates constraints to direct management when successful project completion is at risk
Complies withcompany Department and Standard Operating Procedures
Verifies and ensures adequate supply of test articles and other equipment or material
Required Skills and Experience
Technical Skills:
Familiarity with equipment needed to perform typical performance measurements on electro-mechanical systems.
Some basic knowledge of electrical systems, test equipment, and test practices is desirable.
Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.)
Ability to perform the basic mechanical engineering calculations needed to support equipment design, including dimensional analysis.
Experience with MATLAB, Python, Arduino is a plus
Experience with SolidWorks or similar CAD software is highly preferred
Other skills and abilities:
Proactive and self-motivated engineer.
Must be a quick learner with the ability understand complex products and processes.
Ability to work in a team environment.
Ability to work independently and with minimum supervision.
Ability to multitask, and handle tasks with competing priorities effectively.
Ability to work with biological samples, including blood,tissueand organs.
Familiar with GDP.
Integrity:
Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
Required Education and Training
Minimum BS in Mechanical, Biomedical Engineering or similar degree.
Minimum 2+years work experience in an engineering organization or research team environment.
Working Conditions
The employee will spend time at their desk in front of the computer as well as work in a lab environment.
Lab environment will have exposure to animal blood and tissue; there will also be exposure to detergents and other chemicals used for reprocessing medical devices.
Hands on testing includes but not limited to using the robotic systems, mechanical test fixtures, microscopes, electrical test fixtures etc.
Preferred Skills and Experience
Prefer experience within medical device or pharmaceutical industry.
Experience with SolidWorks or similar CAD software.
Experience with MATLAB, Python, Arduino is highly preferred.
Experience working with electro-mechanical systems is a plus.
