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 Senior Test Engineer will work with a team of dedicated individuals 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 test plans for instrument, accessories, endoluminal, and 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, reports and negotiate 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 and leads 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
Reasoning Ability:
Ability to apply critical thinking to solve problems while leading cross-functional, technical teams in making decisions.
Ability to influence technical stake holders and suggest process improvements
Ability to understand and work on complex products and processes
Other Responsibilities
Ability to collaborate with cross functional teams and contribute to the development of product requirements and risk documents
Effective technical communication across various levels of the organization at core team meetings and design reviews.
Ensures successful, on-time completion of department and core team projects; communicates constraints and recommends preferred mitigation to direct management when successful project completion is at risk
Complies with company Department and Standard Operating Procedures
Effectively translate the functional requirements into appropriate acceptance criteria for testcases and test methods.
Train test technicians on test methods and procedures
Skills, Experience, Education, & Training:
Education and/or Experience:
Minimum of 6+ years experience working in an engineering or research team environment.
Minimum BS in Mechanical, Biomedical Engineering or similar degree. MS preferred.
Prefer experience within medical device or pharmaceutical industry.
Medical Device Verification/Validation experience is required
Understanding of design controls used in the Medical device development is required.
Experience with working through various phases of medical device product development process (concept through launch) is preferred.
Technical Skills:
Ability to perform mechanical engineering calculations needed to support equipment design, including dimensional analysis.
Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.).
Experience with SolidWorks or similar CAD software.
Experience with MATLAB, Python, Arduino is highly preferred.
Experience working with electro-mechanical systems is a plus.
Experience with Test Method Validation is highly preferred.
Experience in Reliability Engineering is a plus.
Other skills and abilities:
Ability to work independently and with minimal supervision.
Ability to multitask, and handle tasks with competing priorities effectively.
Ability to work with biological samples, including blood, tissue and organs.
Familiar with GDP skills.
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
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
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