Hardware Test Engineer 3

Job Description

Primary Function of the Position

The New Product Verification Department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in product and process quality, in new product development and production, and in the quality of da Vinci and Ion robotic product lines, including diagnostic systems, endoscopic instrumentation, and supporting accessories. The Senior Test Engineer will work with a team of dedicated people within a product development team to assure the quality of new designs, to identify issues related to new designs and processes, and to work with other Test Engineers to develop harmonized test methods.

Essential Job Duties

Test Protocol Development, Execution & Reporting

• 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
• Develops clinically relevant test methods ensure design requirements are sufficiently verified by collaborating with appropriate cross functional partners
• Executes test protocols for clinically-based surgical simulation and automated testing utilizing da Vinci surgical system, Ion Systems and/or other test equipment
• Identifies and presents problems that arise during feasibility and design verification testing, and escalates new or persistent failure modes to appropriate engineering teams
• Proactively engages with appropriate engineering teams 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
• Proactively identifies and develops processes and test methods that could benefit from new or updated fixture designs by engaging with design and test engineers
• Perform test fixture qualification as required
• Responsible for documentation of fixtures utilizing SolidWorks; release of documents into Agile

Other Responsibilities

• Effectively translate the functional requirements into appropriate acceptance criteria 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 with company Department and Standard Operating Procedures
• Verifies and ensures adequate supply of test articles and other equipment or material

Qualifications

Required Skills and Experience

• Medical Device Verification/Validation experience is required
• Understanding of design controls used in the Medical device development is required.
• Ability to perform mechanical engineering calculations needed to support equipment design, including dimensional study.
• Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.).
• 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 autonomously and with minimal supervision.
• Ability to multitask, and handle tasks with priorities effectively.
• Ability to work with biological samples, including blood, tissue and organs.
• Familiar with GDP skills.
• Accepting and adhering to high ethical, moral, and personal values in conclusions, communications, actions, and when dealing with others

Required Education and Training

• Minimum experience: 4+ years experience working in an engineering organization.
• Minimum education: BS in Mechanical, Biomedical Engineering or similar degree. MS preferred.

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.