Senior Test Engineer

Job description

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

Qualifications

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