Hardware Test Engineer 3
About the role
The New Product Verification Department at Intuitive is dedicated to ensuring that our products, such as the da Vinci surgical system and Ion, meet the highest standards of safety, reliability, and effectiveness. Our team works closely with surgeons, clinicians, and other stakeholders to develop and validate new designs, identify issues early, and improve the quality of our products.
Responsibilities
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.
Collaborates with cross-functional partners to ensure design requirements are sufficiently verified.
Executes test protocols for clinically-based surgical simulation and automated testing using da Vinci surgical system, Ion Systems, and 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 engineering teams on failure investigation and root cause analysis.
Documents test results and observations in test reports.
Designs test fixtures and other test aids needed for Design Verification and Life/Reliability tests.
Qualifies test fixtures as required.
Documents fixtures using SolidWorks; releases documents into Agile.
Translates functional requirements into appropriate acceptance criteria for test cases and test methods.
Trains test technicians on test methods and procedures.
Ensures successful, on-time completion of department projects; communicates constraints to direct management when necessary.
Complies with company Department and Standard Operating Procedures.
Verifies and ensures adequate supply of test articles and other equipment or materials.
Qualifications
Medical Device Verification/Validation experience.
Understanding of design controls used in Medical device development.
Experience performing mechanical engineering calculations.
Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes).
Proactive and self-motivated engineer.
Quick learner with understanding of complex products and processes.
Ability to work in a team environment.
Ability to work independently and with minimal supervision.
Ability to multitask and handle tasks with competing priorities.
Experience working with biological samples, including blood, tissue, and organs.
Familiarity with GDP skills.
Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.
Education and Training
4+ years experience working in an engineering organization.
Bachelor's degree in Mechanical, Biomedical Engineering, or a similar field.
Master's degree preferred.
Preferred Skills and Experience
Experience within medical device or pharmaceutical industry.
Experience with SolidWorks or similar CAD software.
Experience with MATLAB, Python, Arduino.
Experience working with electro-mechanical systems.