Staff Hardware Test Engineer

Staff Hardware Test Engineer

Requirements

• 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

Responsibilities

• 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
• 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
• 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

Preferred Qualifications

• 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