Staff Hardware Test Engineer

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 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
• Drives failure investigation and root cause analysis in collaboration with other engineering partners
• 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 recommendations.
• Ability to influence technical stake holders and suggest process improvements
• Ability to understand and work on complex products and processes

Other Responsibilities

• Technical leadership when collaborating with the cross functional teams and contributes 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
• Contributes to the strategy for reliability assessment and verification of robotic surgical devices.
• Effectively translate the functional requirements into appropriate acceptance criteria for testcases and test methods.
• Coaches and mentors engineers and technicians in the team

Qualifications

Required Skills and Experience

• Medical Device Verification/Validation experience is required
• Understanding of design controls used in the Medical device development is required.
• Experience with working on through various phases of medical device product development process (concept through launch) is required.
• 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.).
• 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 skills.
• Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

Required Education and Training

• Minimum 10+ years experience working in an engineering organization.
• Minimum 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.
• Experience with Test Method Validation is highly preferred.
• Experience in Reliability Engineering is a plus.