Sr. Hardware Test Engineer

Primary Function of 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 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.

Roles & Responsibilities

Test Protocol Development, Execution & Reporting:

• Develops high level verification and validation test plans for Systems, 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 & Automate 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 Arduino, or other test scripts; release appropriate documentation for the same into document control system.

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

Requirements

Education and/or Experience

• Minimum BS in Electrical, Biomedical Engineering or similar degree.
• Minimum 4+ years work experience in an engineering organization or research team environment.
• Prefer experience within medical device or pharmaceutical industry.
• Device Verification/Validation experience in a regulated industry is required.

Technical Skills:

• Ability to perform the basic electrical engineering calculations, measurements and investigation needed to support equipment design.
• Experience with motors and building motor control circuits preferred.
• Experience with basic circuit design experience preferred.
• Familiarity with equipment needed to perform typical performance measurements on electro-mechanical systems.
• Experience with electronic test equipment such as oscilloscopes, multimeter, signal generators, power supplies, and embedded systems.
• Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.) is a plus
• Experience with MATLAB, Python is desirable.
• Experience with SolidWorks or similar CAD software is a plus .

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 autonomously and with minimal supervision.
• Ability to multitask, and handle tasks with contesting priorities effectively
• Ability to work with biological samples, including blood, tissue and organs
• Familiar with GDP.

Integrity

• Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

Travel

• Role is set schedule and based in Sunnyvale, California. Ability to travel (10%) as needed to support programs at other facilities